CITATION: Taylor v. Canada (Attorney General), 2020 ONSC 1192  
COURT FILE NO.: CV-181819  
DATE: 20200227  
ONTARIO  
SUPERIOR COURT OF JUSTICE  
)
)
BETWEEN:  
KATHRYN ANNE TAYLOR  
) John Legge, Steve Pengelly, David Steeves,  
) and Brian Moher for the Plaintiff  
Plaintiff  
)
)
)
and –  
)
)
)
)
)
)
)
)
)
Sean Gaudet, James Soldatich, Andrew Law,  
James Gorham, Roger Flaim, for the  
Defendant  
THE ATTORNEY GENERAL OF  
CANADA  
Defendant  
James Newland, Neil Wilson for the Ontario  
Health Insurance Plan  
) HEARD: April 1-3, 5, 8-12, 23-26, 29, 30;  
) May 1-3, 6-12, 15, 23-26. 29-31; June 3-5,  
) 10-13, 17-21; September 16-20, 23; October  
) 7-9, 2019  
LEDERER J.  
INTRODUCTION  
[1]  
Government regulates many areas of our lives. This regulatory activity is part of what  
organizes our society, confirms its values and, in some circumstances, gives direction to what we  
can, should or might do. In a culture which values the individual and encourages other  
participants (say universities, research entities and corporations) to find solutions to common  
concerns, locating the balance between public and private responsibility when things go wrong is  
a complicated problem. This case enters into this difficult question but in what turns out to be a  
limited way.  
[2]  
The area being regulated is a form of medical treatment, not the activity of the  
professionals involved (doctors and nurses), or the use of drugs but instead so called “devices”  
that may improve the circumstances of those in need of relief. This includes, for example, any  
apparatus that may be used to augment the structure of the body and improve its function. In this  
Page: 2  
case, Vitek Inc., a corporation located in Houston, Texas was promoting and selling a proprietary  
product (“Proplast”) for a variety of uses associated with an array of physical issues of concern  
to many people. Of particular relevance was its use in implants designed to replace the meniscus  
in the jaw to alleviate discomfort and improve performance. This occurred at a time of growing  
government interest in the entry of these devices into the market and the perceived need for  
increased regulation to meet their arrival. Devices using Proplast were implanted into some  
Canadian citizens. Today, it is generally accepted that Proplast is frangible (fragile, brittle),  
breaks down and that the resulting particles may distribute themselves causing much suffering  
and pain such that the use of the jaw may become restricted, in some cases ineffectual. The  
Plaintiff says that the defective nature of the product was well-known and understood long  
before these implants were put in place. It is said that the fault for the harm that resulted lies, in  
part, with the government for its failure to properly regulate and control the entry of Proplast  
products into the market and its failure to respond appropriately after the difficulties of the  
recipients of these implants became apparent.  
HISTORY OF THIS ACTION  
[3]  
This is a class action. It has a history, not a happy one. The implants which mark the  
beginning took place at some point between 1983 and 1990. This action was commenced in  
1999. It has taken 20 years to bring it to trial. By my count, from the trial record, with the  
delivery of these reasons, no fewer than 23 judicial officers (Masters, Superior Court and Court  
of Appeal judges) will have touched this proceeding.  
[4]  
The initial representative plaintiff was Judith Logan. In 2002 an effort was made to add,  
as a plaintiff, Wendy Bulloch-MacIntosh. She had commenced an individual action. The stated  
purpose of the motion was to add to the certification record information elicited from  
representatives of the Crown during the discovery in that separate proceeding. There was a  
threshold issue. Could the individual action be stayed but left in place if Wendy Bulloch-  
MacIntosh became a representative plaintiff in the class action? Initially, the judge considering  
the matter indicated a willingness to hear further submissions. In the end, the plaintiff withdrew  
the request.1 In 2003, Judith Logan was replaced by Kevan Drady and the present representative  
plaintiff, Kathryn Anne Taylor.2 Kevan Drady withdrew in 2006 to commence a separate class  
action alleging negligence over the regulation, by Health and Welfare Canada, of a different  
implant, that one using “silastic” (a combination of silicone and plastic), not Proplast. That  
action was struck out by the Court of Appeal in 2008 for failing to disclose a reasonable cause of  
action.3  
1 Trial Record at T. 11 and T. 12 (Endorsements of Mr. Justice Winkler respectively dated February 13, 2002 and  
May 15, 2002.)  
2 Ibid at T. 13 and T. 14 (Respectively the Reasons and Order of Mr. Justice Winkler.)  
3 Drady v. Canada, 2008 ONCA 659 (CanLII), 300 DLR (4th) 443, 270 OAC 1, 68 CPC (6th) 306, [2008] OJ No  
3772 (QL), 169 ACWS (3d) 683  
Page: 3  
[5]  
The first substantive issue that comes to mind is whether, given the time lapse, the action  
was commenced outside the applicable limitation periods. At the time, there were two limitations  
that could have impacted this case. The first, 6 years as found in the Limitations Act4, and the  
second the Crown Liability and Proceedings Act5 which, in turn, adopted whatever provisions  
applied in the province where the cause of action arose being, in this case, the Proceedings  
6
Against the Crown Act of Ontario. That Act required that at least 60 days before the  
commencement of an action against the Crown a notice of the claim be served on the Crown.  
The issue of applicable limitations arose as part of a motion heard considering the substitution of  
the original representative plaintiff. The question was whether the substitution could not take  
place because, in the absence of certification, the putative class action remained an individual  
action. This would mean that the “tolling” of the applicable limitation period through the Class  
Proceedings Act, 19927 had not become effective. The motion judge did not accept this  
submission. In any case, as he saw it, there was no need to start a new action. “The most  
appropriate approach to deal with the motion to substitute in the present circumstances is by way  
of amendment, pursuant to the jurisdiction granted to the court under ss. 12 and 14 of the CPA  
[Class Proceedings Act] rather than for the new representative plaintiffs to commence a fresh  
proceeding.”8 Apparently, the issue of whether the action as commenced in the name of Judith  
Logan was out of time did not come up. However, it did in the appeal that followed:  
In any event the motion judge did not deal with that argument and I can only  
assume it was because the argument was not put in that way. In any event,  
however it is clear from the disposition made by the motion judge that because the  
claim is that the breaches by the appellant are continuing, the action was not, on  
its face, barred by the passing of the limitation period.9  
[6]  
of whether this action was out of time has not been raised since. It was not raised at this trial.  
The appeal was dismissed. The substitution was allowed.10 So far as I am aware the issue  
[7]  
The certification of this action as a class proceeding was not finalized until July 6, 2012  
following a determination made by a five-judge panel of the Court of Appeal. What did it take to  
get to that point? During May, 2000, the plaintiff (still Judith Logan) brought a motion to certify  
the action as a class proceeding.11 On October 3, 2000, a motion to strike certain materials  
included in the Motion Record filed, by the Plaintiff, in support of the motion to certify the  
action was heard. Of the six contested items, two were withdrawn, three were struck and for one,  
the issue declared moot.12  
4 R.S.O. 1990, c. L.15  
5 R.S.C., c. C-50  
6 R.S.O. 1990, c. P. 27  
7 S.O. 1992, c. 6, s. 28  
8 Trial Record at T. 13 (Endorsement of Mr. Justice Winkler at paras. 14-25 (The sentence quoted is at para. 25))  
9 Logan v Canada (Minister of Health) 2004 Canlli 184 (ON CA), 71 OR (3d) 451, 188 OAC 294 at para. 15  
10 Ibid and Trial Record at T. 19 (Respectively the Decision and Order of the Court of Appeal both of June 29, 2004)  
11 Trial Record at T. 7 (Endorsement of Master MacLeod dated July 25, 2001) at para. 12  
12 Ibid at T. 4 and T. 5 (Respectively, the handwritten endorsement and Order of Mr. Justice Winkler dated October  
3, 2000.)  
Page: 4  
[8]  
On July 25, 2001, Master MacLeod dealt with a motion, generally, concerning the refusal  
to answer questions during a cross-examination conducted in preparation for a motion to amend  
the pleadings. What is apparent is that the difficulties that have marked the overall conduct of  
this action had already appeared:  
A form of procedural gridlock has arisen over this issue notwithstanding  
admonitions by the case management judge.13  
[9]  
An appearance was necessary to settle the order. The difficulties that had presented  
themselves continued. The Master was required to underscore that the order he had made  
required the deponents to the affidavits to reattend to answer the questions asked, as well as  
reasonable follow-up questions. As the Master noted, while the issue of a re-attendance is  
discretionary, the permission to permit a subsequent examination was, and remains, the “usual  
order”. The Master felt the need to go on:  
I find it an extraordinary submission that the credibility of these witnesses will  
remain an issue on the motion.14  
[10] It seems the Master also had to consider and deal with an allegation of some sort of  
improper conduct of counsel for the Plaintiff:  
I do not view the affidavits provided by Mr. Legge as an improper attempt to  
unilaterally determine the mode of examination but rather as an attempt to provide  
timely answers in a cost effective manner.15  
[11] The Master noted the Crown’s response to whatever problem it saw:  
Nevertheless, the Crown insists on proceeding orally and there has been no  
persuasive argument why this should not be allowed.16  
[12] This all has to do with a refusals motion. One has to wonder why all this obfuscation was  
thought to be necessary.  
[13] The certification motion was considered in reasons delivered on September 5, 2007. The  
action was certified:  
The allegations are consistent with an interpretation that Health Canada's failure  
to take steps to enforce the regulations and its directions to the distributor of the  
devices - despite its knowledge that they were being breached - facilitated the  
13 Ibid at T.7 (Endorsement of Master MacLeod dated July 25, 2001 at para. 12.)  
14 Ibid at T.10 (Endorsement of Master MacLeod dated October 9, 2001, p. 2.)  
15 Ibid at T. 10, p. 2  
16 Ibid at T. 10, p. 2  
Page: 5  
continued sale of the devices and thereby created a risk to the health of the  
intended recipients. Health Canada’s alleged failure to enforce the regulations  
when it was aware that sales of the implants were continuing after it had given  
notice of breaches on a number of occasions over a period of six or seven years,  
could only have encouraged the importer/distributor to believe that it could ignore  
its statutory obligations, and Health Canada’s warnings, with complete impunity.  
In these circumstances, I believe it would be open to a court to find that Health  
Canada’s course of conduct – including the dissemination of the misinformation  
in its database - increased the risk to the health of the plaintiff and other potential  
recipients of the implants and gave rise to a relationship of proximity with them.17  
[14] The Court pointed out the limits of this determination:  
It is possible that the plaintiff will not be able to prove the allegations of fact in  
the statement of claim - or that a different complexion may be placed on them  
when all the evidence on each side is before the court at trial. These are not  
matters I am concerned with on this motion.  
[15] But went on to confirm the then pertinent conclusion:  
On the basis of the pleading alone, I do not consider it to be plain and obvious that  
Ms. Taylor has no chance of success in establishing that a relationship of  
proximity as required to establish a private law duty of care existed in  
connection with operational acts of Health Canada. I believe this conclusion is  
consistent with the cases I have cited, and others18  
[16] A motion was brought to the Divisional Court seeking leave to appeal the order certifying  
the class action. Leave was refused.19  
[17] This was not the end of the Court considering the question of certification of the  
proceeding as a class action.  
[18] A year after the certification motion, the Court of Appeal released its decision in Drady v.  
Canada.20 It too considered implants to the jaw. In that case, in this Court, the year before, the  
same judge, as on the certification motion, had struck the Statement of Claim. Proximity was not  
apparent because the plaintiff was unable to identify the particular implant he had received as  
being manufactured by Vitek Inc.:  
17 Taylor v. Canada (Health), 2007 CanLII 36645 (ON SC), 285 DLR (4th) 296, 49 CPC (6th) 36, [2007] OJ No  
3312 (QL), 160 ACWS (3d) 385 at para. 39  
18 Ibid at para. 40. (The other citations referred to at the end of the quotation are: Sauer v. Canada (Attorney  
General),2007 ONCA 454 (CanLII), [2007] O.J. No. 2443 (C.A.); Swanson Estate v. The Crown (1991), 1991  
CanLII 8226 (FCA), 80 D.L.R. (4th) 741 (F.C.A.); and Williams v. Canada (Minister of Health) (2005), 2005 CanLII  
29502 (ON SC), 76 O.R. (3d) 763 (S.C.J.))  
19 Taylor v. Canada (Attorney General), 2007 CanLII 55708 (ON SCDC), 289 DLR (4th) 567, 233 OAC 111, —  
[2007] OJ No 4947 (QL), 163 ACWS (3d) 368  
20 Supra (fn. 3)  
Page: 6  
In these circumstances independently of any other considerations - the facts  
alleged with respect to the Crown's operational negligence with respect to the  
Vitek Proplast implants are, in my judgment, insufficient to give rise to  
relationship of proximity between it and Mr Drady. Under the FDA and the  
regulations, the Crown does not regulate devices generically or by categories. Its  
powers and responsibilities are confined to dealing with particular devices sold, or  
to be sold, in Canada on a case by case basis. The Crown's alleged negligence in  
respect of the defaults of the Vitek Proplast implant vendor cannot create  
proximity with Mr Drady if it is not alleged that he received such a device.  
Independently of any other consideration, a causal relationship between the  
plaintiff, the device and its vendor is an essential link in the creation of a  
relationship of proximity. …21  
[19] The device implanted in Kevan Drady did not use or contain Proplast. It relied on silastic.  
The Court of Appeal in Drady considered the Superior Court decisions in both that case and this  
one. It confirmed the decision that, in Drady, there was no proximity between the Crown and the  
plaintiff. There being no proximity, it was plain and obvious that the action could not succeed.  
[20] At about the same time as the decision of the Court of Appeal in Drady v. Canada it also  
released its reasons in Attis v. Canada22 which considered the same issues, albeit in relation to  
breast implants rather than jaw implants. The legislative scheme did not demonstrate any  
intention to impose a private law duty of care23 and there was no direct communication or  
interaction between the government and the plaintiff in relation to the operation or  
implementation of a policy such that a duty of care could arise. There was no allegation of any  
representations by Health and Welfare Canada that were capable of supporting a relationship of  
proximity.24  
[21] Both Drady and Attis made reference to Sauer v. Canada (Attorney General).25 It runs  
counter to their determination concerning the absence of proximity. In Sauer, a farmer  
commenced a class action as a result of a cow, in Alberta, contracting “BSE” (colloquially “Mad  
Cow Disease). Some countries closed their borders to Canadian beef. The law suit was for  
negligent regulation of the cattle industry and claimed for the financial losses suffered as a result.  
In certifying the action, the judge considering the motion held that a duty of care had been  
disclosed in the pleadings. The Court of Appeal made this observation even though the judge had  
not directly addressed the question.26 The motion judge had moved directly to the issue of  
21 Drady v. Canada, 2007 CanLII 27970 (ON SC), [2007] CarswellOnt 4631, [2007] OJ No 2812 (QL), 159  
ACWS (3d) 177 at paras. 23 and 24  
22 2008 ONCA 660 (CanLII), 93 OR (3d) 35, 300 DLR (4th) 415, 254 OAC 91, 59 CPC (6th) 195, [2008] OJ No  
3766 (QL) , 169 ACWS (3d) 684  
23 Attis v. Canada (Health), supra (fn. 22) at para. 62  
24 Ibid at para. 66 and 68  
25 Sauer v. Canada (Attorney General), 2007 ONCA 454 (CanLII), 225 OAC 143, 31 BLR (4th) 20, 49 CCLT (3d)  
161, [2007] OJ No 2443 (QL), 159 ACWS (3d) 306  
26 Taylor v Canada (Health), 2010 ONSC 4799 (CanLII), 81 CCLT (3d) 106, [2010] OJ No 5936 (QL) at para. 30  
Page: 7  
whether there was a policy rationale for overriding the finding of proximity and the resulting  
duty of care as required by the second stage of the test in Anns v. Merton London Borough  
Council.27 In Sauer v Canada (Attorney General) the Court of Appeal upheld the certification. It  
dealt with the issue of proximity in a single paragraph:  
On the other hand, Sauer argues that he has pleaded the facts required to show  
sufficient proximity between Canada and commercial cattle farmers to raise  
a prima facie duty of care. In particular, he points to the many public  
representations by Canada that it regulates the content of cattle feed to protect  
commercial cattle farmers among others. He says this shows that Canada was  
acting with their interests in mind rather than the broad public interest. Sauer says  
that Canada’s public assumption of a duty to Canadian cattle farmers to ensure the  
safety of cattle feed yields the conclusion that it is not plain and obvious that his  
claim of a prima facie duty of care will not succeed. I agree.28  
[22] Drady and Attis having been decided and based on what they determined, the Crown  
moved, in this action, to strike the Statement of Claim and decertify the class action. The Court  
determined that the pleading failed to disclose a reasonable cause of action but granted the  
plaintiff leave to amend the Statement of Claim. The Court denied the motion to decertify the  
class action.29  
[23] In coming to its decision, the Court took account of how each of Drady and Attis dealt  
with Sauer:  
The treatment of Sauer in these cases is typified by the following comments  
in Attis and Drady:  
[In Sauer] this court found a sufficient pleading of proximity at  
para. 62 on the basis of the many express "public representations  
by Canada that it regulated cattle feed to protect commercial cattle  
farmers among others" (emphasis added). Accordingly, the  
result in Sauer depended on the allegation of specific  
representations by the Government that it was acting in the  
interests  
of  
the  
plaintiffs.  
On  
this  
basis, Sauer is  
distinguishable because the appellants in this case do not plead any  
specific representations by Health Canada that it was acting to  
protect the particular interests of the consumers of breast implants.  
(Attis at para 49)  
27  
[1977] UKHL 4, [1978] AC 726 (The test established in Anns v. Merton London Borough Council, though later  
rejected in England, is still relied on in Canada. It is a broad test for determining the existence of a duty of care. The  
test has two stages. It requires first a sufficient relationship of proximity based upon foreseeability; and secondly  
considerations of reasons (policy) why there should not be a duty of care.)  
28 Sauer v. Canada (Attorney General), supra (fn. 25) at para. 62  
29 Taylor v Canada (Health), supra (fn. 26) at paras. 26, 49, 54 and 76  
Page: 8  
Proximity was also adequately pleaded in Sauer on the basis of the many express  
public representations by the government that it was acting for the explicit  
purpose of protecting the commercial cattle farmers. These representations  
supported the plaintiffs allegation that the government assumed a private law  
duty to act on behalf of the farmers. (Drady at para 42)30  
[24] And concluded:  
The significance attributed to the representations in Sauer would appear to have  
considerable precedential importance for counsel and motions judges when  
considering the kind of representations by the Crown that could give rise to a  
sufficiently close relationship with the plaintiff.31  
[25] In the end it was not plain and obvious that the proximity necessary to demonstrate a  
private duty of care could not be met:  
In these circumstances, I believe I should accept the amended pleading on the  
ground that when it is read generously - it is not plain and obvious that a finding  
of proximity could not be made at trial if the factual allegations pleaded are  
proven. At the very least, in view of the need for clarification of the requirements  
for an effective public assumption of a private law duty of care, I consider  
that this is a case in which it should be held that the particular issue on which  
proximity turns is not fully settled in the jurisprudence within the meaning of the  
decisions cited in paragraph 47 above. In such cases it has been held that the issue  
in dispute is best left to be dealt with at trial on the basis of a full evidentiary  
record.32  
[26] Instead of proceeding to the Divisional Court and recognizing the confusion the mix of  
cases then extant had caused, the Crown determined to move directly to the Court of Appeal. A  
motion was brought for leave to have a special case determined. The judge opened his reasons  
observing that “[t]his action has had a tortured history”.33 It was 10 years after the action had  
been commenced. There had been no progress. The motion was granted, in part out of concern  
for the delay:  
The parties have indicated to me that this litigation has already become a  
procedural marathon. If the case was to follow through the normal course in the  
Divisional Court with leave to appeal and appeal in the Divisional Court,  
followed by the inevitable application for leave to appeal to this court and the  
appeal in this court, then several more months -- if not a couple of years -- will  
30 Taylor v Canada (Health), supra (fn. 26) at para. 35  
31 Taylor v Canada (Health), supra (fn. 26) at para. 37  
32 Taylor v Canada (Health), supra (fn. 26) at para. 73  
33 Taylor v. Canada (Attorney General) 2011 ONCA 181, 104 OR (3d) 481, 277 OAC 126, [2011] OJ No 949 (QL).  
(A Notice seeking leave to appeal to the Divisional Court, dated September 15, 2010 was filed but no action taken  
pending the outcome of the motions seeking a special case (at para. 19).)  
Page: 9  
have passed. This action was commenced in December 1999 and pleadings have  
not yet closed. So much for access to justice!  
It is time to get this case moving ahead…34  
[27] It is this order that placed the matter before the panel of five judges of the Court of  
Appeal. In its decision the Court of Appeal picked up on the general understanding outlined in  
Attis to the effect that the proximity necessary to found a duty of care can arise from the  
legislation or through direct interaction between the regulator and the individuals impacted:  
The approach taken to the claims in Drady and Attis is consistent with that  
described above. In both cases, this court looked first at the relevant legislative  
scheme and found that it imposed no private law duty of care: see Attis, at  
paras. 53-62; Drady, at paras. 37-39. The court then turned to the pleadings in  
each case to determine whether the interactions between the regulator and the  
plaintiff set forth in the pleadings created a relationship of proximity such as to  
justify a finding of a prima facie duty of care.35  
[28] The Court rejected the finding, apparent in the determination in Sauer, that the “many  
public representations” made by the regulator as to its intention to protect farmers was sufficient  
to support a finding of the proximity required as the basis for the existence of a duty of care:  
In my view, a finding of proximity based entirely on a regulator's public  
acknowledgement of its public duties to those affected by its actions, coupled  
with reliance by those affected on the regulator's public statements, is inconsistent  
with the Supreme Court's rejection in Imperial Tobacco of the claim that Health  
Canada owed a private law duty of care to consumers of low-tar cigarettes  
because it had made public representations as to the relative safety of those  
cigarettes.36  
[29] The Court concluded:  
This is not the time or place to pass upon the ultimate sufficiency of the  
pleadings in Sauer. I am satisfied, however, that the detailed analyses of  
proximity in Attis and Drady, particularly in the light of the subsequent judgment  
in Imperial Tobacco, are more in line with the prevailing jurisprudence. The  
single conclusory observation in Sauer, standing alone, is not consistent with that  
jurisprudence.37  
34 Ibid at paras. 27-28  
35 Taylor v. Canada (Attorney General), 2012 ONCA 479 (CanLII), 111 OR (3d) 161, 352 DLR (4th) 690, 293  
OAC 312, 95 CCLT (3d) 88 at paras. 92  
36 Ibid at para 95  
37 Ibid at para. 97  
Page: 10  
[30] However, the Court of Appeal was not prepared to foreclose the possibility of the  
required proximity being available to the Plaintiff. The inquiry is broader than looking for  
immediate and direct interaction between the regulator and the prospective plaintiff:  
Where the legislation is not determinative one way or the other, the courts explore  
the specific circumstances of the interactions between the regulator and the  
plaintiff in the context of the legislative scheme to decide whether a sufficiently  
"close and direct" relationship exists to justify the imposition of a prima facie  
duty of care38  
[31] The Court addressed the substance of that inquiry:  
Findings of proximity based on the interactions between the regulator and the  
plaintiff are necessarily fact-specific. The jurisprudence does, however, suggest  
there are two important factual features in those cases where the court has found a  
prima facie duty of care.39  
[32] And explained the two factual features it found important:  
First, the facts demonstrate a relationship and connection between the regulator  
and the individual that is distinct from and more direct than the relationship  
between the regulator and that part of the public affected by the regulator's  
work.40  
And  
The second feature of those cases in which the courts have found that the  
interactions between the plaintiff and the regulator created a prima facie duty of  
care arises out of the nature of the duty actually imposed by the legislative  
scheme. While the statutory duties are found to be public duties and not,  
therefore, themselves the basis for any private law duty of care, those public  
duties have been found to be consistent with the existence of a private law duty of  
care owed to an individual plaintiff.41  
[33] On this basis the Court concluded:  
38 Ibid at para. 79 referring to R. v. Imperial Tobacco Canada Ltd., [2011] 3 S.C.R. 45, [2011] S.C.J. No. 42, 2011  
SCC 42 (CanLII), at para. 50; Hill v. Hamilton-Wentworth Regional Police Services Board, [2007] 3 S.C.R.  
129, [2007] S.C.J. No. 41, 2007 SCC 41 (CanLII), 285 D.L.R. (4th) 620, at paras. 26-45; Fullowka v. Pinkerton's of  
Canada Ltd., [2010] 1 S.C.R. 132, [2010] S.C.J. No. 5, 2010 SCC 5 (CanLII), at paras. 37-55; Heaslip Estate v.  
Mansfield Ski Club Inc. (2009), 96 O.R. (3d) 401, [2009] O.J. No. 3185, 2009 ONCA 594 (CanLII), 310 D.L.R.  
(4th) 506, 67 C.C.L.T. (3d) 1, 252 O.A.C. 1, 179 A.C.W.S. (3d) 1224 at paras. 15-31.  
39 Ibid at para. 80  
40 Ibid at para. 80  
41Ibid at para. 88  
Page: 11  
The jurisprudence permits no definitive answer for the first question. As counsel  
for AG Canada put it in his factum, "[t]he requirements for proximity are diverse  
and depend on the facts of each particular case".42  
[34] The Court of Appeal did not stop there:  
there is no allegation of any direct contact between the plaintiff [Kathryn  
Taylor] and Health Canada43  
[35] However, the possibility of proximity remained:  
In my view, it is arguable that the misrepresentations, combined with the failure  
to correct that misrepresentation in the face of knowledge of the serious and  
ongoing risk posed to a clearly definable and relatively small group of consumers,  
could be viewed as akin to the regulator's failure in Fullowka to act in the face of  
the known and ongoing dangers posed to the small and well-defined group of  
miners who worked in the specific mine which the regulator knew to be unsafe.44  
[36] With this, the action was certified and proceeded as a class action.  
[37] Why review this history now? It is unacceptable that it has taken as long as it has for this  
action to proceed to trial. The case is premised on the idea that there is a group of people who  
have been harmed by the alleged neglect of the government. They have been waiting for twenty  
years, their suffering continuing, presumably with the hope, maybe even the expectation, of  
some assistance. No one should be content with the time this has taken. Those involved have to  
ask why they allowed this to happen. Moreover, what the reasons of the Court of Appeal  
demonstrate is that the foundational question to be answered: Did the government owe the  
members of the class a private duty of care, is a limited one. No duty of care is imposed by the  
legislation. Nor, in this situation, is there proximity as a result of direct and immediate  
interaction. What is left is narrow. Is there some identifiable group to which, as a result of some  
action by the government, proximity exists and a duty of care attaches?  
[38] This is not the only limitation imposed through the history of this unfortunate litigation.  
[39] It should go without saying that there are other parties who would have been involved in  
the importing, marketing, selling, purchasing, implanting and observing the results of any  
surgery associated with the placing of Vitek Proplast devices. These would include the  
manufacturer, the distributor, the hospital and various doctors and other professionals. Not  
surprisingly, given that the only defendant in this action is the Crown, it issued Third Party  
Claims. The Trial Record includes an order, dated September 14, 2006, allowing the Crown, on  
consent, to deliver its Amended, Amended, Amended, Amended Third Party Claim.45 There is  
42 Ibid at para. 92  
43 Ibid at para. 107  
44 Ibid at para. 111  
45 Trial Record at T. 23  
Page: 12  
no earlier form of the Third Party Claim in the Trial Record. Clearly, it had been subject to a  
series of changes. There is another order, this one issued on September 25, 2005, as I read it, in  
furtherance of the amendment allowed 10 days earlier. It allowed for the discontinuance of the  
Third Party action against those that, with the amendments that had been ordered in place, were  
no longer the subject of any allegations in the Third Party Claim.46  
[40] The motion that determined that, in Drady, the Statement of Claim disclosed no  
reasonable cause of action was joined by a motion to strike the Third Party Claims in both Drady  
and this case. The question that arose concerned what the Plaintiff was claiming and, in  
particular, did it leave open the prospect that the Crown, if found liable, could have a claim to  
contribution and indemnity as allowed for by the Negligence Act.47 At the outset, counsel for the  
Plaintiff was insistent that the Plaintiff’s claim perceived that the Crown was liable for all of the  
damage she had suffered. Counsel for the moving parties (the Third Parties) relied on “a few  
references to the Crown’s several liability that appeared in the Plaintiff’s pleadings”.48 The Court  
determined that “several” liability did not foreclose the possibility of contribution from others:  
I do not believe there is any doubt that the great majority of situations in which a  
right to contribution arises in practice involve several, rather than joint,  
tortfeasors.49  
[41] On this basis, one would expect that the motion was dismissed. It was. But not before  
counsel for the Plaintiff had a change of heart. On a subsequent appearance, counsel indicated a  
willingness to make clear that while the position remained that the Crown was liable for all the  
damage suffered, should it be found that others shared the blame, the Plaintiff was seeking an  
award only for the Crown’s proportionate share. This being so there would be no basis for a  
claim for contribution. The motion was dismissed but on the understanding that it was open to  
the Plaintiff to amend the Statement of Claim to make clear that the liability of the Crown was  
limited to its relative degree of fault. An application could then be made for a declaration with  
respect to that relative degree of fault.  
[42] The order was appealed. By the time the appeal was heard, the Statement of Claim had  
been amended to meet the suggestion of the motion judge. Thus, there was no basis for a claim  
46 Ibid at T. 24  
47 R.S.O. c. N.1 Section 1 states:  
Where damages have been caused or contributed to by the fault or neglect of two or more  
persons, the court shall determine the degree in which each of such persons is at fault or  
negligent, and, where two or more persons are found at fault or negligent, they are jointly and  
severally liable to the person suffering loss or damage for such fault or negligence, but as  
between themselves, in the absence of any contract express or implied, each is liable to make  
contribution and indemnify each other in the degree in which they are respectively found to be at  
fault or negligent.  
48 Drady v. Canada, supra (fn. 21) at para. 62  
49 Ibid at para. 64  
Page: 13  
for contribution. The appeal was dismissed. The Court of Appeal took it that the motion judge  
had struck the Claim and that he was right to do so.50  
[43] This is another limitation as to what can be accomplished in this trial. The Court of  
Appeal, in dealing with the Third Party claim, observed that the Court maintains the jurisdiction  
to apportion fault against a person not a party to the action or, as put by the Court of Appeal:  
“…nothing in the language of s. 1 [of the Negligence Act51] precludes a court from doing so.”52  
No one is asking for this kind of apportionment. In this situation it would not be appropriate as a  
common issue. The answer would be, or could be, different for every member of the class  
depending on who was involved and what role they played. Thus, all that can happen in this  
common issues trial is the recognition that there was a duty of care owed and that it was, or was  
not, breached. Nothing can be done to assess the degree of fault or the proportion of the liability  
attributable to any party. Still it seems not unreasonable to propose, as a possibility, that once  
any liability of the manufacturer, distributor, doctors, hospitals and others are accounted for, any  
degree of liability attributable to the government might be small, in relative terms and as to its  
value.  
[44] Another limitation is in respect of the class. How many people are there who could  
benefit from a finding in favour of the class? Not many.  
[45] How was the class to be defined?  
…The classes that the plaintiffs seek to represent consist of persons resident in  
Canada, outside British Columbia and Quebec, who received the TMJ implants.53  
[46] This is a highly generalized statement. A true understanding of the class requires  
refinement. I begin by repeating that the reason Kevan Drady’s individual action failed is  
because he was unable to identify Vitek Inc. as the manufacturer of the implant he had received:  
In this case, although the allegations relied on by the plaintiff appear to relate to  
the same implants (Vitek Proplast implants) of the same vendor/importer whose  
breaches of duty were allegedly ignored by the Crown in Baric, it is not pleaded  
that Mr. Drady received any such implant.54  
[47] This class action concerns those who received Vitek Inc. Proplast temporomandibular  
joint (jaw) implants. What follows from Drady is that if the individual did not receive one of  
these implants, he or she cannot be a member of the class:  
50 Taylor v. Canada (Health), 2009 ONCA 487 (CanLII), 95 OR (3d) 561, 309 DLR (4th) 400, 264 OAC 229,  
[2009] OJ No 2490 (QL)  
51 R.S.O. 1990 c N.1  
52 Taylor v. Canada (Health), supra (fn. 50) at para. 27  
53 Drady v. Canada, supra (fn. 21) at para. 1  
54 Ibid at para. 22  
Page: 14  
It follows that the scope any duty of care that might exist between the Crown and  
those who received the Vitek Proplast implants cannot, in my opinion, extend to a  
person who did not receive them.55  
[48] Understood in this way, membership in the class is narrowly defined: implants made by a  
particular manufacturer, utilizing a proprietary product in its manufacture (Proplast), implanted  
without the requisite acceptance by the regulator (the granting of a Notice of Compliance), where  
the recipient or his caregivers were misled into believing a Notice of Compliance had been  
granted when they had not been, or, in circumstances where the Notice of Compliance, though  
issued, should not have been.  
[49] All of this when the suggestion is that there were few of these implants used in Canada.  
There have been doubts about the numbers since the beginning. The following paragraph appears  
in the reasons responding to the first certification hearing, the one that took place during June  
2007 with the decision being released on September 5, 2007:  
Plaintiff's counsel estimated the size of the class to be approximately 2600  
individuals. The evidence in support of a number this large is not persuasive. The  
estimate is based on information from Health Canada that 26,000 Vitek TMJ  
implants were distributed in the United States and an assumption that, based  
simply on the relative populations of Canada and the United States, "it would not  
be unreasonable" to conclude that 2,600 units were implanted in Canada. The  
information from Health Canada on which counsel relied only in part suggests  
that the class might not exceed 200 persons.56  
[50] To the Court of Appeal, at the hearing of the special case, the assumption was that the  
group was small:  
In my view, it is arguable that the misrepresentations, combined with the failure  
to correct that misrepresentation in the face of knowledge of the serious and  
ongoing risk posed to a clearly definable and relatively small group of consumers,  
could be viewed as akin to the regulator's failure in Fullowka to act in the face of  
the known and ongoing dangers posed to the small and well-defined group of  
miners who worked in the specific mine which the regulator knew to be unsafe.57  
[51] This perception is fundamental to the ultimate determination made by that Court. The  
finding that it was not plain and obvious that the action could not succeed was based on the  
understanding that the interaction that was the foundation of the required proximity was to other  
than those affected by the regulator’s regular work, by definition a smaller group. Inspite of all of  
this, as late as November 27, 2018, a motion was brought before Master McGraw who, while  
acknowledging that some members would have died, understood the size of the class to have  
55 Ibid at para. 25  
56 Taylor v. Canada (Health), supra (fn. 17) at para. 60  
57 Taylor v. Canada (Attorney General), supra (fn. 35) at para. 111  
Page: 15  
“approximately 2500 -2600 members.58 The Submissions of the Plaintiff made at the end of the  
trial use the same estimate.59  
[52] As will become apparent later in these reasons, there is some reason to wonder whether  
any of the individuals who testified are, in fact, members of the supposed class. This leaves open  
the prospect that there is no class.  
[53] There are serious limitations to the impact of any decision the Court may render. There is  
only a narrow route to the necessary proximity; it is only the alleged negligence of the Crown  
that is at issue, its proportionate share of liability, if any, cannot be determined as a common  
issue and the size of the class cannot be determined but could be small.  
[54] In this consideration of the history, I move on to production. This was an issue of  
controversy throughout the twenty years leading to this trial which continued, despite the efforts  
of the Court to bring it to an end, up to and including the last days of the trial. It does not reflect  
well on the parties, either of them. To my mind, it contributed substantially to the delay in  
bringing this matter to resolution.  
[55] On October 17, 2003, Master MacLeod released reasons in a motion dealing with  
production.60 Viewed from the perspective of the time (the beginning of the process) it was both  
comprehensive and prescient. It concerned the fundamental obligations of the Crown:  
(1) Was it obliged to swear an affidavit of documents in the usual form?  
(2) What was the range of documents to be produced?61  
(3) Given the volume of documents to be produced and the production of copies on  
CD ROM, what special rules should apply?62  
58Taylor v. Attorney General of Canada, 2018 ONSC 7235 (CanLII) at para. 7  
59 Submissions of the Plaintiff at para. 3  
60 Logan v. Harper, 2003 CanLII 15592 (ON SC),  
61 Ibid at para. 3(b):  
i)  
type of TMJ implant apparently used in the plaintiff’s jaw?  
ii) For the purpose of these cases, what are “documents” and is it necessary to disclose file  
Are all documents relating to TMJ implants relevant or only those relating to the specific  
folders, file folder tracking information and other documents disclosing who had possession of  
or access to particular files at specific times?  
iii)  
is there only an obligation to disclose relevant documents retrieved from files?  
iv) What is the extent of the obligation to provide a complete and comprehensive Schedule  
Are files in their original form and order “documents” within the meaning of the rules or  
C to the affidavit or list of documents?  
62 Ibid at para. 3(c) a list was provided, as follows:  
i)  
Should the defendant be required to share its software for searching the CD ROM  
version of the documents?  
Page: 16  
(4) Should Health Canada disclose how the search for documents was conducted,  
who conducted it and what search criteria were used?  
[56] In answering the questions that were put to him, the Master made an observation pointing  
to the problem the parties faced:  
A large document case, requires a specific plan for organized access to the  
documents. Tracking document locations and permitting inspection of originals is  
particularly problematic if the documents or files are required for the day to day  
operations of an organization or if they may be subject to production in more than  
one proceeding and may be required in the future. In such situations, the  
immediate production obligation must be balanced against the need to maintain  
the ongoing viability of the filing system. Production obligations can be onerous  
and disruptive to an organization and some balance must be struck.63  
[57] He made plain the risk and advised as to the solution:  
Finally, to avoid complete chaos on both sides, the organization and production of  
the documents for the purpose of the litigation should ideally utilize a jointly  
accepted plan of organization, authentication, identification and retrieval. What is  
necessary therefore is definition of the scope of production, a production  
procedure that is understood and accepted and liberal doses of procedural  
collaboration and common sense. In these actions, I invite counsel to agree on the  
plan but if agreement cannot be achieved, court management and supervision of  
the production and discovery process appears necessary.64  
[58] The Master understood that, in this situation, there were practical limits to the process:  
The plaintiffs wish paper copies of every document and wish to inspect every  
original document. As I understand it they also wish to see every document in its  
original file folder in original order and they wish production of the file tracking  
documents or stamps which are believed to show who within Health Canada had  
possession of any file and at what time. In the particular circumstances of this  
case with the volume of documentation involved, that demand is unrealistic,  
onerous, expensive and excessive. It is unnecessary for every document to be  
subjected to this level of scrutiny. There is a right to inspect original documents  
ii)  
Notwithstanding the production of scanned, indexed and potentially text searchable  
versions of the documents, is the plaintiff entitled to insist upon inspection of every original  
document?  
iii)  
Must Health Canada provide paper copies of the documents in addition to the CD ROM  
versions?  
63 Ibid at para. 27  
64 Ibid at para. 27  
Page: 17  
and there may be relevance to file tracking information or file organization but it  
is necessary for such rights to be exercised in a focussed and targeted manner.65  
[59] All of which speaks to the clear-headed observation that some cooperation and  
understanding needed to be applied to the difficulties of this particular document search.  
[60] Fifteen years later, on October 29, 2018, a motion was brought before Master McGraw.  
The motion was, in part, for an order striking out the Statement of Defence for “…the alleged  
failure to produce documents pursuant to court orders, specifically the order of Master MacLeod  
(as he then was) dated October 17, 2003”.66 This was taken in the face of a trial date that had  
been set by Mr. Justice Firestone, a year earlier, on October 31, 2017. The Master was aware of  
the problematic nature of this request. He wondered if some other remedy, one that would allow  
the action to continue to trial, had been considered. He was advised that a proposal had been  
made by the Plaintiff and rejected by the Crown. The motion began. Counsel for the Plaintiff, at  
the conclusion of his submissions (approximately three hours into the motion) changed his  
position. He advised the Court that rather than the striking of the defence, the Plaintiff was  
seeking an order requiring further production including examination of a non-party, a former  
employee of Health and Welfare Canada. The Crown was unable to respond. It had prepared to  
answer what the Master referred to as the Plaintiff’s “aggressive and exclusive pursuit of  
dismissal of the Defence”.67 The Master was confronted with a problem. As he saw it, even if the  
Court was to make the order on that day, it was not practical to expect that it could be complied  
with by the trial date that had been set, January 14, 2019:  
Given the age and volume of the documents sought, some of them over 30 years  
old and others which may no longer exist or are in dated electronic format that  
must be located and searched, I am not satisfied that all steps contemplated by the  
Proposed Order can even be completed in time for trial, let alone in time for any  
documents produced or examination transcripts to be used as evidence at trial.  
Further, if the Defendant wishes to oppose certain terms of the Proposed Order, it  
is entitled to additional time to properly respond to the Plaintiff’s change of  
position and the late filed materials. All of this must be balanced with the  
Plaintiff’s entitlement to relevant documents prior to trial, particularly in a  
procedurally and substantively complex matter such as this.  
[61] It seems there was the risk of a further motion seeking a further examination:  
Further, there is still the possibility that the Defendant will be bringing a motion  
to examine Dr. Blais68  
65 Ibid at para. 28  
66 Taylor v. Attorney General of Canada, 2018 ONSC 6808 (CanLII) at para. 1  
67 Ibid at para. 7  
68 Ibid at para. 8  
Page: 18  
[62] The Master, relying on rules 37.02(2)(b) and 1.04 adjourned the motion sine die (without  
a day), and returned the matter to Mr. Justice Firestone for directions with respect to the fixed  
trial date, the motion and the changed relief being sought by the plaintiff.  
[63] Justice Firestone issued a procedural order on November 5, 2018. A new trial date was  
set, April 1, 2019, peremptory to all. The parties were ordered to attend before Master McGraw,  
on November 27, 2018 and November 29, 2018, for the return of the motion. To ensure there  
were no further delays, Mr. Justice Firestone added as a term of his order that there were to be no  
further motions prior to trial other than those that might be heard by the trial judge.  
[64] The motion was brought back before the Master who released his reasons on December  
3, 2018. There were no fewer than ten motions (eight by the plaintiff, two by the Crown), all  
dealing with production and requests for further examinations.69 The situation confronting the  
Master was complicated by the history and the circumstances:  
69 Ibid at para. 1:  
i.)  
the Plaintiff’s motion to compel the AGC to locate and produce copies of all versions of the report  
prepared on May 28, 1981 by Dr. Pierre Blais, the Plaintiff’s key witness and a former research scientist in  
Health Canada’s (“HC”) Medical Devices Bureau from 1976 until 1989, entitled “Plastic Fluid Handling  
Systems and Implanted Devices: Rationale for regulatory amendments” (the “1981 Report”) together with  
audit trails and search parameters as evidence of such efforts;  
ii.)  
the Plaintiff’s motion to compel the AGC to locate and produce electronic versions of all  
documents for which the AGC disputes authenticity;  
iii.)  
the Plaintiff’s motion to compel the AGC to locate and produce publication and/or presentation  
approval sheets for all papers prepared by Dr. Blais together with the underlying documents submitted in  
support of such approval requests;  
iv.)  
v.)  
the Plaintiff’s motion to compel the AGC to produce Dr. Blais’ personnel file;  
the AGC’s motion to compel the production of Dr. Blais’ original documents for forensic  
examination;  
vi.)  
the AGC’s motion to compel answers to undertakings and refusals arising from the examination of  
Dr. Blais on September 26, 2018;  
vii.)  
the Plaintiff’s motion for the continued examination for discovery of Dr. William Freedland on  
refusals from his discovery and questions properly arising therefrom, or, in the alternative, an order that Dr.  
Freedland be examined pursuant to Rule 31.10;  
viii.)  
the Plaintiff’s motion to take the evidence of Dr. Napke, Dr. Neville, Dr. Blais and Kathryn Taylor  
before trial pursuant to Rule 36.01;  
ix.)  
x.)  
the AGC’s motion for the examination of Dr. Blais pursuant to Rule 31.10; and  
the AGC’s motion to take the evidence of Francine Jacques and Dr. Noel Rose prior to trial  
pursuant to Rule 36.01.  
Page: 19  
These 10 motions proceed in less than ideal circumstances. This is a 19-year,  
procedurally and substantively complex class proceeding where the parties have  
been engaged in ongoing production disputes for over 15 years. The documents  
produced and sought are voluminous with many of them over 30 years old and  
some even over 40. Some documents may no longer exist, previous searches may  
not have located them and the potential places to search for documents is  
overwhelming. Combined with the fixed peremptory trial date of April 1, 2019,  
this strikes at the heart of proportionality and requires a balancing of the parties’  
entitlement to know the case they must meet through the production of relevant  
documents and right to oral discovery prior to trial and the efforts and costs  
imposed on the other party. Quite simply, there is not enough time until trial to  
complete the additional, comprehensive procedural steps which the parties seek  
and which would be ideal for a case of this nature in the current circumstances.70  
[65] Master McGraw recognized that there had been delay, that both parties were at fault:  
With the volume of available and searchable documents and a trial commencing  
in 4 months, it is not possible to reconcile all of the parties’ positions and  
allegations with respect to the Production Motions. They have not been resolved  
over the last 15-plus years and there is no time to resolve them now. Both parties  
must bear responsibility for the delayed, late and inadequate productions over the  
last two decades and no purpose would be served in determining who is more to  
blame at this time. This includes issues arising from the AGC’s alleged and/or  
apparent non-compliance with the 2003 Order and Master Haberman’s directions  
and the Plaintiff’s late delivery of documents in the possession of her key witness  
19 years into the proceedings and 21 years after his involvement with related  
actions. It is also inevitable that the de-certification, appeal and related pleadings  
amendments have also contributed to the delays and complexity of these  
proceedings. In my view, any allegations regarding the sufficiency, timing and  
propriety or production are more appropriately issues for costs, either on these  
motions or at trial, together with whatever conclusions or inferences the trial  
Judge may draw generally. Allegations of spoliation are more appropriately an  
issue for the trial Judge in any event (Muskoka Fuels v. Hassan Steel Fabricators  
Ltd., [2009] O.J. No. 4782 (S.C.J.) at paras. 5-7).71  
[66] Master McGraw considered each of the ten motions. The decisions he made ordered  
some targeted searches and some specific searches; some to be done electronically, with the  
provision of a description in each case of the Crown’s best efforts including where it searched,  
the search terms; and at least one physical search (material associated with Pierre Blais). Orders  
were made requiring two witnesses (Pierre Blais and Francine Jacques (Gaudette)) to be  
examined, one in Toronto and the other in Montreal, and for the Plaintiff to submit  
interrogatories to be answered by various of the Crown’s employees (Dr. Freedland, Dr. David  
70 Taylor v. Attorney General of Canada, supra (fn. 58) at para. 5  
71 Ibid at para. 21  
Page: 20  
Taylor and Lindsay Blaney). Time limits were imposed: 45 days for some of the items ordered,  
by February 28, 2019 for others and 60 days for the interrogatories.  
[67] What is clear is the intention of both Mr. Justice Firestone and Master McGraw that this  
would be the end of what had been an ongoing dispute concerning production. It was not. On  
March 19 and 20, 2019, less than two weeks before the trial was to begin, the Crown produced a  
book of fresh documents. Counsel for Plaintiff submitted he had been asking for some of them  
over an extended period of time. Not surprisingly, the Plaintiff complained. This required an  
appearance on March 22, 2019. Counsel for the Plaintiff cited the long history of attempts to get  
complete production from the Crown. Counsel asked for an adjournment. Counsel for the Crown  
acknowledged that some of the documents should have been produced earlier but also suggested  
that the Plaintiff was already aware of some of those that were the subject of this late production.  
The adjournment was refused. A series of directions were provided to overcome the difficulties  
the situation presented. Among them, that of the documents that were the subject of the motion,  
the only ones that could be produced at trial were those the Plaintiff agreed to or those the  
Plaintiff indicated an intention to rely on.  
[68] There was a further and subsequent complaint. During March 2018 the Plaintiff produced  
some documents from Dr. Pierre Blais. He had had the documents for at least 30 years. The  
Crown had indicated an intention to question the authenticity of certain of those documents. This  
was among the ten motions heard by Master McGraw and considered by him in his reasons of  
December 3, 2018. Expert reports were referred to. The Plaintiff did not have them. This  
spawned another request for an adjournment by the Plaintiff. The adjournment was refused but  
the issue delayed to be dealt with after all the other evidence was completed, if the Crown  
remained intent on raising the issue.  
[69] As late as September 13, 2019, the Friday before the trial was to resume following a ten  
week break, with only one defence witness remaining to be called, counsel for the Plaintiff wrote  
to the Court seeking a motion for directions for, among other things, production and  
examinations surrounding the issue of the authenticity of the impugned documents of Pierre  
Blais. Counsel for the Crown responded by letter, the same day, sparking a response, in turn,  
from counsel for the Plaintiff which included the following paragraph:  
Mr. Gaudet’s letter revives the Plaintiff’s concerns about the AGC’s continuing  
non-compliance with prior production Orders. This noncompliance vitiates the  
Plaintiff’s ability to advance her case. Relevant documents were and continue to  
be withheld from production and discovery. Trial fairness cannot be restored  
without focussed remedial relief and sanction.  
[70] I have reviewed the letter from Mr. Gaudet. I am hard pressed to understand how it would  
be a catalyst for going back to Master MacLeod’s order of October 17, 2003. It does not matter.  
What this exchange demonstrates is that to the very end, 16 years after the order of Master  
MacLeod, the parties continued to battle over productions. Like Master McGraw I see no  
purpose in trying to assess blame. I say only that it is clear that the injunction of Master  
MacLeod, that cooperation was required, was not adhered to. This was to the detriment of the  
parties and to the proceeding.  
Page: 21  
THE COMMON ISSUES  
[71] Out of the history of this proceeding and its certification was the identification of the  
common issues to be dealt with in this trial. They are:  
(1) Did Canada owe a duty of care to class members?  
(2) If so, did Canada breach the applicable standard of care?  
(3) If so, can Vitek Proplast temporomandibular joint implants cause injury to those  
receiving them?  
THE REGULATORY REGIME  
[72] The Food and Drugs Act was passed in 1920. Statutory provisions specifically dealing  
with medical devices were first enacted on May 14, 1953 and came into force on August 16,  
1954.72 The Food and Drugs Act was introduced at the material time, as it is now, as “An Act  
respecting food, drugs cosmetics and therapeutic devices”.73 What is a “medical device”? The  
Food and Drugs Act did defined the term “device”:  
“device” means any article, instrument, apparatus or contrivance, including any  
component, part or accessory thereof, manufactured, sold or represented for use in  
(a) the diagnosis, treatment, migration or prevention of a disease,  
disorder or abnormal physical state, or the symptoms thereof, in  
man or animal,  
(b) restoring, correcting or modifying a body function or the body  
structure of a man or animal,  
(c) the diagnosis of pregnancy in humans or animals, or  
(d) the care of humans or animals during pregnancy and at and  
after birth of the offspring, including care of the offspring,  
and includes a contraceptive device but does not include a drug.74  
[Emphasis added]  
[73] For the purposes of these reasons, we are concerned with subparagraph (b).  
Temporomandibular joint implants replace the meniscus that separates two elements of the jaw,  
the fossa and the condyle, to allow for its proper movement.75  
72 Agreed Statement of Facts at para. 13  
73 R.S.C. 1985 c. F. 279 (The definition has since been amended)  
74 R.S.C. 1985 c. F. 27 at s. 2  
Page: 22  
[74] Beginning in December 1954 and through August 1975 deviceswere also subject to  
the provisions of the Food and Drug Regulations. The concern for and interest in the regulation  
of medical devices galvanized in and around 1975. This was occasioned by two unfortunate  
examples: the Dalkon Shield, an intrauterine contraceptive device, and the nuclear batteries  
utilized in pacemakers inserted into the heart. The former caused infection; the latter  
disintegrated in the body. A third factor was the “beginning of intraocular surgery”.76 As a result,  
on September 2, 1975, the Medical Devices Regulations, a regulation specific to these devices,  
was introduced.77 Among other things, the Medical Devices Regulations govern the entry of  
devices into the market in Canada. From the outset, the Medical Devices Regulations prohibited  
the importation into Canada of any device the sale of which would violate any part of the Food  
and Drugs Act or the Medical Devices Regulations.78 On March 25, 1977, a limited form of pre-  
market review was introduced into the Medical Devices Regulations.79 It was restricted to “new  
devices”. “New devices” were, and remain in the current version of the regulations, defined as:  
“new device”, in relation to a manufacturer, means a device listed in the table to  
this Part that  
(a) has not been sold previously in Canada by that manufacturer,  
(b) it is, in respect of any characteristic, different from any device  
sold previously in Canada by that manufacturer, or  
(c) is, in respect of all characteristics, identical with a device sold  
previously in Canada by that manufacturer that has previously  
been recalled or withdrawn from the market or that he has ceased  
to manufacture or sell.80  
[Emphasis added]  
[75] As of the promulgation of the Medical Devices Regulations on March 25, 1977, the  
“device[s] listed in the table to this Part” included only: (1) Intra-uterine devices and (2) Cardiac  
75 The Agreed Statement of Facts at para. 42 describes the temporomandibular joint as follows:  
The TMJ is comprised of the condylar head of the mandible, the glenoid fossa of the temporal  
bone and an interposed articular disc. Additionally, these structures are supported by a joint  
capsule and ligaments and are connected to the muscles of mastication.  
76 Transcript of Pierre Blais (April 26, 2019) at pp. 49-51  
77 Consolidated Regulations of Canada (1978) Volume VIII, Ch 871  
78 SOR/75-526 at s. 15 and Consolidated Regulations of Canada (1978) Volume VIII, Ch 871 at s. 16:  
Subject to section 19 [subsequently s. 20], no person shall import into Canada for sale a device  
the sale of which in Canada constitute a violation of the Act or these Regulations.  
79 Agreed Statement of Facts at para 18 referring to Medical Devices Regulations, amendment SOR/77-258,  
Schedule II, s.28  
80 SOR/77-258 at s. 28 (in the current consolidated regulation s. 32)  
Page: 23  
pacemakers. A manufacturer of a “new device” was prohibited from selling or advertising that  
device unless the manufacturer received a Notice of Compliance from Health and Welfare  
Canada. To obtain a Notice of Compliance, the manufacturer was required to submit to Health  
and Welfare Canada evidence establishing the safety and efficacy of the new device. On October  
8, 1982, the Table to Part V of the Medical Devices Regulations was amended to extend the pre-  
market review to any “new device” designed to be implanted into the tissues or body cavities of  
a person for 30 days or more.81 This amendment became effective on April 1, 1983. From this, it  
is apparent, and it was not disputed, that what in 1977 was Part IV of the Medical Devices  
Regulations and is now Part V applied to the Vitek Proplast Implants that are at the centre of this  
proceeding. To be clear it was understood and accepted by all parties that in order to be  
mandated for sale in Canada these products required Notices of Compliance. It should be said  
that a Notice of Compliance allows the product involved to be sold and used in Canada.  
However, it signifies only that the submissions made in support of the application “complied”  
with the legislative requirements. A Notice of Compliance is not a statement by the government  
that the product is safe, only that the work required to justify its entry into the Canadian market  
according to the tests set out in the Medical Devices Regulations has been completed. In short, a  
Notice of Compliance is not a guarantee, by the government, that the device is safe for use and  
will assist in reducing pain or benefit the problem being treated. The review it conducts is as to  
the sufficiency of the work; it is not a peer review as to how it was conducted or a replication  
that confirms the results. The legislation makes clear that the responsibility to conduct proper  
studies lies with the manufacturer.  
[76] At the time the submissions seeking Notices of Compliance for the products of interest to  
this case were made there was some suggestion, by those applying, that the product had been  
“sold previously in Canada” and that they should be “grandfathered” and not treated as “new  
devices”. Documents that purported to confirm those sales were not accepted as such by the  
representatives of Health and Welfare Canada. As the Plaintiff has asserted, and as the Defendant  
has readily conceded, they had to be treated as they were, that is, as new devices to which the  
requirements of Part V of the Medical Devices Regulations applied.  
81 Agreed Statement of Facts at para. 21 and Consolidated Regulations of Canada (1978) Volume VIII, Ch 871 and  
Medical Devices Regulations, amendment SOR/82-914:  
SCHEDULE  
The table to Part V of the Medical Devices Regulations is revoked and the following substituted  
therefore:  
3. Any device designated to be implanted into the tissues or body cavities of a person for 30 days  
or more.  
Page: 24  
[77] There were criteria applicable to the content and assessment of the submissions made to  
support the request for any Notices of Compliance for “new devices”. Under the heading:  
Submission” the Regulation noted:  
s. 35(1) For the purpose of obtaining a notice of compliance, the manufacturer of  
a new device shall submit to the Director  
(a)  
evidence of the safety of the device consisting of at least  
(i)  
the name and mark under which the devices to be sold,  
the purpose of the device and its method of use,  
the performance characteristics of the device,  
(ii)  
(iii)  
(iv)  
the specifications and limits set for those materials of the  
device that may come in contact with body tissues or fluids and a  
summary of the test methods used to ensure conformity with those  
specifications and limits,  
(v)  
if sold as sterile, the method of sterilization and the  
recommended method of resterilization, if applicable,  
(vi)  
a general description of the plant, equipment and  
procedures used in the manufacture of the device,  
(vii) the quality control program and procedures used ensuring  
manufacturing, packaging and sterilization of the device, and  
(viii) that full data of all chemical studies, analysis and animal  
studies carried out to determine the bio-compatibility of those  
materials of the device that may, in the normal use, come in  
contact with body tissues or fluids;  
(b)  
evidence of the effectiveness of the device, consisting of at least  
(i)  
the results of all clinical trials to show the effectiveness of  
the device,  
(ii)  
where clinical trials have not been made, the results of  
animal studies or appropriate tests that demonstrate a probability of  
effectiveness in humans, and  
(iii) all known adverse reactions or contra-indications to the use  
of the device under the recommended conditions; and  
Page: 25  
(c)  
drafts of all labels, package inserts, product brochures and file  
cards to be used in connection with the device.  
(2) Where the Director is of the opinion that the evidence and materials submitted  
by a manufacturer pursuant to subsection (1) are not sufficient for him to  
determine whether or not he should issue a notice of compliance for the purpose  
of selling or advertising the new device, the Director may require the  
manufacturer to submit to him further information concerning the device or any  
samples of any of the ingredients or components of the device and of the device  
itself.  
[78] Under the heading: “Issue of Notice of Compliance”:  
s. 36. Within sixty days after the latest date of the receipt by the Director of  
evidence, materials or information submitted by a manufacturer under section 35,  
(a)  
where that Director is satisfied that the manufacturer has provided  
substantial evidence that  
(i)  
the conditions of production and quality control are suitable for  
controlling the quality, stability, safety and performance of the new  
device,  
(ii)  
the new device can be used for the purpose and under the  
conditions of use recommended by the manufacturer without undue risk to  
humans,  
(iii) the new device is clinically effective for the purpose and under the  
conditions of use recommended by the manufacturer or that sufficient animal  
studies have been carried out to establish a probability of effectiveness in humans,  
and  
(iv)  
the drafts of all labels, package inserts, product brochures and file  
cards to be used in connection with the device are adequate,  
the Director shall issue to the manufacturer a notice of compliance; or  
(b)  
where that Director is not satisfied that the manufacturer has provided the  
evidence referred to in paragraph (a), the Director shall refuse to issue a notice of  
compliance and shall notify the manufacturer of his refusal and of the reasons  
therefore.82  
82 SOR/77-258 s.31 and s. 32 (in the current consolidated regulation s. 35 and s. 36)  
Page: 26  
[79] Accordingly, the regulation, in the form applicable when the requests for Notices of  
Compliance were made, first in 1987 and again in 1988, continued to require a demonstration of  
both “safety” and “efficacy”. As was acknowledged by at least two witnesses called by the  
Plaintiff83, these two requirements do not stand as independent standards to be treated and  
considered separate and apart, one from the other. They are not absolute tests measurable on a bi-  
lateral basis: either safe or not safe; either effective or not effective. Instead they function as two  
ends of a spectrum: at one end devices which are safe but do nothing to alleviate the illness or  
disfunction which requires treatment, and at the other end, devices which may cure the concern  
but at the price of some other undeniable harm. Obviously, neither of these two extremes would  
generate the issuance of a Notice of Compliance. The determination of whether to issue a Notice  
of Compliance is a consideration of where, on the continuum between these two extremes, taking  
into account the degree and likelihood of relief measured against the risk of further harm, the  
predicted functioning of the device may fall and whether on that basis it is appropriate to issue a  
Notice of Compliance:  
Q. And we hear the terms evidence of safety and efficacy throughout the last  
month. Can you give us your overview of what that means?  
A. Safety and efficacy are the two essential attributes that are demanded of a  
medical device, offered up matter of drug as well. It is a quantity that is measured  
against the importance of the need that it fulfills. For example, a product can be  
highly efficacious and very safe, but totally useless medically. Conversely a  
product can be extremely dangerous and would have a strong possibility of being  
an inefficacious but is essential surgically. The balance between the two is the  
area that we are now discussing.84  
[80] What this demonstrates is that there is no, and can be no, certain or definitive answer. It is  
a balancing and, thus, inherently contains a high degree of discretion and consideration specific  
to the individual case.  
[81] The limitation imposed by the regulation sets the context in which the choice is to be  
made. There is a time limit. The decision is to be taken within 60 days. This is not much time to  
consider the kind of detailed studies new approaches to science and treatment, by their nature,  
require. Hence the proposition that the determination to be made is not as to the rectitude of the  
studies but as to whether they comply with the regulations that govern these submissions.  
[82] The evidence shown by the studies was required to be “substantial”: first in showing  
“safety” measured as use “without…undue risk” and second, either clinical efficacy (efficacy  
demonstrated through trials on humans) that shows the device to be effective under the  
conditions of use recommended by the manufacturer or efficacy shown through animal studies  
that establish a probability of effectiveness in humans.  
83 Transcript of Pierre Blais (April 26, 2019) at pp. 71-73 and Transcript of Richard Lawuyi (May 27, 2019) at  
pp.43-46  
84 Ibid (Pierre Blais) at p. 71  
Page: 27  
[83] The answer as to whether a Notice of Compliance should be issued is to be arrived at  
within the time frame set and consistent with the standards to be met. Finding the balance  
between “safety” and “efficacy” reflects on the two competing policy values at the core of the  
regulatory scheme. On the one hand, our desire to have those in the industry find, develop and  
produce devices that will assist those who are suffering and on the other to avoid causing more  
harm. Later in these reasons I will be referring to “Cotrel rods” which were, and may still be,  
implanted in some, particularly teenagers, to assist in remedying curvature of the spine. Surgeons  
complained because these devices could not be sold and used because the necessary Notices of  
Compliance had not yet been issued. They wanted to help their patients. They had to wait for the  
issuance of a Notice of Compliance that was first refused pending the delivery of more  
information and later granted. On the other hand, it is generally known (I believe I can take  
judicial notice) that Dalkon Shields which were made available for sale were not sufficiently  
tested and caused considerable damage. The policy formulation is directed to avoiding both these  
results but inevitably will not always succeed. Heather Sheardown is a Professor in the  
Department of Chemical Engineering at McMaster University. I will say more about her  
qualifications later in these reasons. For the moment I only point out an example she provided  
where despite the best intentions, the balance failed. A cornea transplant was approved by the  
Federal Drug Administration in the United States in 2001. It was received by thousands of  
patients. By 2007 the failure rate of 50% became widely known. Some patients went blind.  
Heather Sheardown noted that in many cases we simply do not know what the long-term impacts  
of these new medical devices will be.85 Nirmala Chopra, who was for a time, in charge of the  
premarket review of medical devices, advised the court that there was an expectation that some  
new devices would cause some difficulty and that generally they would be identified within the  
first five years of any new device entering the market.  
PROPLAST  
[84] Proplast is a trademark that is used to describe a family of composite materials that were  
designed, manufactured and sold by Vitek Inc., a Houston-based company founded by Dr.  
Charles Homsy in 1969.86 Proplast is composed of a fluorocarbon polymer matrix and a  
reinforcing material, such as fibre or powder. The fluorocarbon polymer matrix includes  
Polytetrafluoroethylene (“PTFE” commonly referred to as Teflon) and may include Fluorinated  
Ethylene Propylene (“FEP”) polymers and/or fluorocarbon polymer fibres. The reinforcing fibres  
or powder may be an organic or inorganic material, including carbon fibre, aluminum oxide or  
hydroxyapatite. The added fibres or powder are intended to provide enhanced mechanical  
strength while the fluoropolymer is intended to provide a chemically inert, continuous host  
material, or polymer matrix.87  
[85] Proplast has been produced in at least three standard types: Proplast I (PTFE/carbon  
competent material), Proplast II (PTFE/aluminum oxide competent material) and Proplast HA  
85 Transcript of Heather Sheardown (May 30, 2019) at pp. 45-46  
86 Agreed Statement of Facts at para. 43  
87 Agreed Statement of Facts at para. 44 referring to Exhibit 8: Expert Report of Dr. Christopher K. Ober, August  
24, 2018  
Page: 28  
(PTFE/hydroxyapatite competent material).88 Proplast has been manufactured in a variety of  
forms including films, sheets, blocks and coatings. In each case, Proplast may be different –  
different composition, different manufacturing processes and different physical and chemical  
properties.89 All types of Proplast have in common soft PTFE fluorocarbon polymer resin and  
fibre that dominate their surface properties and form a porous matrix. The Proplast types are  
distinguished by differences in the filler that lead to differences in mechanical and other physical  
properties between the Proplast types.90  
[86] The Plaintiff does not agree that the various Proplast products are different. Relying on  
the evidence of Elliot Wayne Tunis, a physician who had implanted Vitek Proplast  
temporomandibular implants, the Submissions of the Plaintiff (the written submissions presented  
on her behalf at the conclusion of the trial) note:  
There was no difference between the Proplast IPIs and Proplast sheeting with  
Teflon laminated to it, other than that the IPIs were manufactured from these  
sheets by cutting the sheet into an anatomic size.91  
[87] What is important is that for the purpose of regulating the devices in issue, those  
responsible for premarket review of the many Proplast products saw differences. As we shall see,  
the complaint made at the time the first applications for Notices of Compliance were received  
was that they had been lumped together such that it was not possible to attribute the supporting  
data to the specific devices to which it applied. The applications were refused. When a second  
attempt was made, the same concern arose. Eventually the regulator (not the applicant) organized  
the devices into eight groups, presumably to assist Vitek Inc. Even so, as will become apparent,  
the various Vitek Proplast products were treated differently. Some were issued Notices of  
Compliance (Proplast Block and Sheeting); many were not (Proplast IPI’s).  
[88] Proplast was used as a material component of temporomandibular joint implants  
produced by Vitek Inc. and available to Instrumentarium Inc. to be distributed in Canada.  
Proplast was intended to anchor the implant to the upper bone of the temporomandibular joint.  
it’s porous nature and potential for tissue ingrowth were intended as a feature that would  
encourage stability in the temporomandibular joint.92 Over time it became apparent that the  
PTFE (Teflon) included as part of certain forms of Proplast could, after being implanted,  
fragment, delaminate or otherwise be damaged. Debris in the joint from implants could  
contribute to progressive bone degenerative change and giant cell reaction.93 In time there was a  
product recall.  
88 Exhibit 51 at T. 1 (Expert Report of Dr. Doran Ryan, July 28, 2018) at p. 21  
89 Exhibit 8 (Expert Report of Dr. Christopher K. Ober, August 24, 2018) at p 5  
90 Ibid at p. 6-7  
91 Submissions of the Plaintiff at para. 20 in turn footnoting Tunis Transcript page 66. (The evidence of Elliot  
Wayne Tunis was in the form of a Cross-examination conducted in another proceeding. The basis for its acceptance  
as evidence in this trial is reviewed at para. [178] herein.)  
92 Agreed Statement of Facts at para. 48  
93 Ibid at para. 114  
Page: 29  
WHAT WAS KNOWN ABOUT PROPLAST, BY WHOM AND WHEN WAS IT KNOWN  
[89] Science does not tend to develop understanding in moments of immediate and complete  
insight. Rather it evolves over time. Robert Pilliar testified at the trial. He is an engineer by  
training but has worked, taught and studied in the area of medical devices for many years. When  
he first appeared, he seemed to acknowledge this perspective but when called in Reply he  
demurred. As he perceives it, evolution is a process generally applicable in biology. As he sees  
it, science does not evolve so much as it moves through steps.94 For the purposes of these reasons  
such a distinction does not matter. The point is that our understanding of science changes and  
becomes more complete as our knowledge and experience increase. Nonetheless, movement “in  
steps” suggests a linear progression (both forward and backward). Evolution in its current  
understanding is a broader concept. Among its definitions:  
A process of change in a certain direction…a process of continuous change from  
a lower, simpler or worse to a higher, more complex or better state…a process of  
gradual and relatively peaceful social, political and economic advance…a theory  
that the various types of animals and plants have their origin in pre-existing types  
and that the distinguishable differences are due to modifications in successive  
generations… a process in which the whole universe is a progression of  
interrelated phenomena95  
[90] Each of these meanings connotes continuous and gradual change that can occur in a  
variety of circumstances. In this case, in the overall appreciation of the risks and harm associated  
with Proplast, one of the issues raised was whether this potential should have been appreciated  
sooner by Health and Welfare Canada such that entry into the market of any Proplast related  
product, at least for use as temporomandibular joint implants, should never have taken place,  
should have been recalled sooner and patients directly advised of the risks. To analyse this  
proposition (and using what has become a too often used colloquialism) it is important to come  
to an understanding of who knew what and when they knew it.  
[91] The evidence addressing the question of the degree and timing of any understanding  
concerning the usefulness of Proplast products began with Pierre Blais. He was a research  
scientist employed by the Medical Devices Bureau (and its successors) from its inception until  
his departure in 1989. In the context of this trial, he was a controversial figure. From the  
perspective offered by the Plaintiff, Pierre Blais was central to the understanding, within Health  
and Welfare Canada, of Proplast and its dangers. Attention was drawn to meetings and  
conferences he said he attended, papers he wrote, a book he contributed to and warnings he said  
he instilled in more senior officials at Health and Welfare Canada. With a closer look, the idea of  
this pivotal role dissipates in the uncertainty and confusion that accompanied his participation in  
the events he referred to and in the trial. He left his employment with Health and Welfare Canada  
under difficult circumstances. He was terminated for an alleged failure to comply with internal  
94 Transcript of Robert Pilliar (September 23, 2019) at p. 24-25  
95 Merriam Webster’s Collegiate Dictionary, Tenth Edition Copyright 1993  
Page: 30  
policy governing, among other things, release of information to the media.96 He grieved. The  
grievance was settled. He was reinstated but retired a day later.97 He was called as a witness, not  
by the Crown, but on behalf of the Plaintiff. He had been available to the Plaintiff’s counsel for  
many years. Even so, in 2017, he produced documents that had not previously been seen.98 He  
happened on them when going over files he maintained in his home. The authenticity of four of  
these documents was questioned by the Crown. At a pretrial conference during the weeks leading  
up to the commencement of the trial, counsel for the Plaintiff advised they were unprepared to  
deal with the issue. One of the reports on which the Crown sought to rely had not been delivered.  
The Plaintiff required time to retain an expert, prepare a response. This resulted in one of the  
adjournment requests to which I have already referred. This was refused. The issue was set aside.  
The documents in issue were to be admitted without reference to their authenticity. That issue, if  
the Crown still intended to proceed with it, would be heard in a separate proceeding at the end of  
the evidence but before final submissions were made. Although not without difficulty, as the end  
of the evidence approached, that is what happened.  
[92] I will refer to each of the four documents as they become relevant. This is provided at the  
outset of these reasons in response to a proposition put in the “Submissions of the Plaintiff”. It is  
said there that the allegations made against Pierre Blais should be rejected. This is not surprising  
but it is not all that was submitted. Counsel for the Plaintiff goes on:  
But in the aftermath of those findings, the Plaintiff submits that Dr. Blais’  
evidence must be accepted as true. Indeed the AGC resiled from its decision to  
call Health Canada witnesses who would have been in positions to refute Dr.  
Blais’ evidence.99  
[93] In other words, as counsel sees it, if the four documents are found to be authentic, there  
need be no further inquiry into the reliability of what those documents say, or it would seem, the  
value of any of the other evidence provided by Pierre Blais. To my mind, this is wrong in a  
profound way. If the documents are authentic, their reliability, probative value and impact in  
contrast to what others have said would remain open for the Court to examine. I go further. It  
would be a failure of the Court, in carrying out its responsibilities, if it did not do so. If the  
Crown had other relevant evidence that it could have called and chose not to do so, that is a risk  
it took.  
[94] For all of his experience, the Plaintiff did not seek to qualify Pierre Blais as an expert. In  
the Submissions of the Plaintiff, Pierre Blais is referred to as a non-party, lay witness”. He is  
not a party but I am uncertain as to the implication of his being a “lay witness”. It is undeniable  
that he was employed through the material time, by Health and Welfare Canada, at the Medical  
Devices Bureau, through whatever name changes and restructuring that occurred during that  
96 Exhibit 34 at T. 11 (Letter dated July 14, 1989 Dr. A. J. Liston to Pierre Blais.)  
97 Ibid at T. 12 (Settlement Offer)  
98 Transcript of Pierre Blais (May 10, 2019) at p. 425-428 and 442-443  
99 Submissions of the Plaintiff at para. 152  
Page: 31  
period. The meaningful distinction, at least as I understand it, is as a “fact” as opposed to an  
“expert” witness. I take this to be the import of the Submissions of the Plaintiff where the  
following is said:  
The Plaintiff called Dr. Blais as a lay witness because of his first-hand knowledge  
that Health Canada’s middle and senior management knew that Proplast was  
unsafe from the early 1980’s onward.100  
[95] I mention this because much of the evidence of Pierre Blais dealt with the state of  
knowledge concerning Proplast as time progressed. What may be interpreted as fact today may  
not have been understood as such at an earlier time. As will become apparent as these reasons  
proceed, what the Plaintiff, relying on Pierre Blais, believes should have been understood early  
in the progress of these events is not so certain. This is especially so when the evidence of Pierre  
Blais is fully examined and considered in the context of what was said by others. At the time,  
perhaps still, there are experts who do not agree with what the Plaintiff takes to be fact. Some of  
this is better understood, at least at the times in question, as opinions. Nonetheless, so far as I can  
recall (there were 55 days of evidence) not once was the evidence given by Pierre Blais objected  
to as crossing from fact to opinion. I take his evidence to be demonstrative of what he saw as fact  
but which others may have seen differently. I believe this to be consistent with the evidence and  
how it was provided but also sensitive to the understanding that broad scientific acceptance is not  
generally a matter of immediate insight but the result of the sort of evolution that occurs over  
time as experience increases knowledge.  
[96] As explained by Pierre Blais, the Medical Devices Bureau was formed in 1975. It was a  
consolidation of those parts of the Health Protection Branch that were concerned with non-drug  
health care products. Pierre Blais recalled that he was the fifth employee brought into the new  
Bureau.101 The catalyst for this consolidation was the appearance of non-drug medical devices  
(such as the Dalkon Shield, pacemaker batteries and the beginning of intraocular surgery), and  
the need for the responsibility for their regulation to have a home. As depicted by Pierre Blais  
this reorganization was not a well-planned response to the developing concerns. “It was  
opportunistic in a sense. It was done piecemeal. And there was no precedent…”102  
[97] In summer of 1976, Pierre Blais attended a Gordon Conference.103 While the origins,  
source and substance of “a Gordon Conference” was not reviewed, it seems that this was one of a  
series of such conferences covering wide areas of scientific interest. Dr. Charles Homsy, the  
person recognized as the developer of Proplast, made a presentation. It concerned Proplast and  
its properties. Those in attendance were identified by Pierre Blais as “one half of the  
100 Ibid at para. 148  
101 Transcript of Pierre Blais (April 26, 2019) at p. 47)  
102 Ibid at p. 51  
103 At first Pierre Blais recalled this conference as taking place during 1977. However, the program of the conference  
says it was 1976 (Exhibit 34 v. 1 T. 15) as do the notes prepared, at the time, by Pierre Blais (Exhibit 34 v. 1 T. 16).  
(p. 15) see also Transcript of Pierre Blais (May 10, 2019) at p. 483  
Page: 32  
contributors to the biomaterials of tissue and bone in the world104[Emphasis added]. He stated  
his own immediate response:  
I was very disappointed by the lecture, but other attendees had other views.105  
[98] He went on to describe the general reaction of those in attendance. It was more than  
disappointment. It was outrage. As witnessed by Pierre Blais the scene was one of  
“pandemonium.” Charles Homsy was besieged by questions from an audience angered by what  
he was saying. As outlined by Pierre Blais, the expressed concerns included:  
why Doctor Homsy was promoting the use of a product where the components  
were individual carcinogens or collective carcinogens, firstly. The second  
concern was that they were complaining that the mere totality of his formula were  
so irritating that they would produce an outright rejection reaction on simply  
being there. A third concern was that the photographs and the photo micrographs  
that Doctor Homsy had shown before showed the Proplast to be disintegrating and  
they had not discussed this.  
It was the overlying, the fact that the material did not have enough strength to  
remain together and that the debris was being disseminated throughout the tissue  
and the living organism through fluids, such as the lymphatic fluid were the key  
concern to the whole thing and was the basis for why the audience was very  
unfavorably inclined.106  
[99] This evidence was anecdotal. There is no data, analysis, report or reviewable assessment  
of any potential risk on which a regulator could rely in examining the overall value of the  
product. There are some handwritten notes made at the time by Pierre Blais. They include  
negative comments with respect to another of the presenters (“PURE BULL” repeated 13 times)  
but only technical observations insofar as what was said by Charles Homsy.107 Even so, those at  
Health and Welfare Canada took account of what Pierre Blais described. Upon his return he  
reviewed what had taken place with his immediate superior, Dr. Ronald Campbell and the  
director of the Medical Devices Bureau, Dr. Ajit DasGupta. As Pierre Blais recalled, they met  
with the personnel of the Bureau responsible for those devices treated by Part V of the Medical  
Devices Regulations (“new devices”) as well as those responsible for the notification  
requirements applicable to other medical devices.108 The investigation went beyond the Bureau  
104 Transcript of Pierre Blais (April 26, 2019) at p. 123  
105 Ibid at p. 122-123  
106 Transcript of Pierre Blais (April 26, 2019) at p. 124-125  
107 Exhibit 27 v. 3 at T’s A, B, C and D  
108 To my mind there is some confusion in this, given that the amendments to the Medical Devices Regulations  
which introduced the concept of “new devices” did not become effective until March 25, 1977. At the time it was  
introduced, it was Part IV. In any case, the point is that at the time those responsible followed up on the information  
brought back by Pierre Blais from the Gordon Conference of 1976.  
Page: 33  
through telephone calls with, and visits to, parties known to be reliable. A conclusion was  
reached. The product was not being sold in Canada through any recognized means or distributor.  
[100] In the period following the Gordon Conference, Pierre Blais says he continued to raise  
concerns:  
Q. Between 1977 and your ultimate final leaving of Health and Welfare Canada  
at the end of 1989, were you engaged in any debate with any co-worker at Health  
and Welfare Canada of any rank about the safety of Proplast?  
A. Yes.  
Q. With whom?  
A. The mere totality of the early generation of evaluators and then later in formal  
lectures that I would give to other members of the department who were not part  
of the Bureau, specifically, the field operations group. I recollect, and I may even  
have notes about a lecture that I delivered on frangible implants in connection  
with the Montreal group, and in connection also with the Toronto field operations  
group.109  
[Emphasis added]  
[101] Pierre Blais told the Court that by 1981 there was a common view extant in Health and  
Welfare Canada that the product was “damaging”:  
Q. I’m asking if there was any debate within Health and Welfare Canada that  
there was a safe use or an efficacious use for Proplast?  
A. Such debates did take place, but only in the academic sense. There was  
unanimity in the belief that the product was very much damaging from certainly  
1981 onward, and that was general. It was not just one, one view, or even the  
official view of our directorship, it spread to everybody...110  
[Emphasis added]  
[102] To suggest that there was no one at Health and Welfare Canada who wondered whether  
the product had value is not accurate. Dr. John Orpin, Medical Advisor, Division of Clinical  
Assessment, Bureau of Medical Devices111 voiced a caution that patients not be deprived of  
something useful.112 As put by Pierre Blais this was explained as follows:  
109 Transcript of Pierre Blais (April 29, 2019) at pp. 11-12  
110 Ibid at p. 14  
111 Exhibit 27 v. 3 at T. H (Letter January 17, 1985 (Dr. J.A. Orpin to Dr. M.T. Cooper)  
112 Transcript of Pierre Blais (April 29, 2019) at p. 108  
Page: 34  
John Orpin, who was also a colleague and a co-worker under Dr. Campbell, and  
his comment was that how did he put it he said but what if perchance it has  
some value. By declaring it unsuitable and unacceptable, could we be depriving a  
patient of something that could be useful. But it was not a criticism. It was not  
someone who supported Proplast. Quite on the contrary. He was simply  
advocated that could we possibly have made mistake. It was the only exception.113  
[103] The source of any information that contributed to this “unanimous belief” was Pierre  
Blais. No additional work or research was referred to. There is no suggestion that over these  
years any notification or application for a Notice of Compliance, along with the data that would  
be required with such a submission, was received for any Proplast product, much less for use as a  
temporomandibular joint implant. There is no suggestion that prior to 1981 there were any sales  
or use of Proplast temporomandibular joint implants in Canada.114  
[104] The evidence, taken as a whole, suggests that Pierre Blais did not play the role he has  
defined for himself. Some of the employees at the Health Protection Branch had never met him,  
others say he played no role they are aware of in respect of Proplast and others say his primary  
interest was with the difficulties being encountered with breast implants. There were people who  
disagreed with him. They were referred to by Pierre Blais as dissenters:115  
113 Ibid at p. 107  
114 At Exhibit 27 v. 1 T.7 and T. 11, Exhibit 34 v. 2 T. 84 and Exhibit 73 T. 4 at p. 14 there is reference to two  
Proplast-like knee implants:  
A Canadian Dow Corning representatives [sic]in Montréal recently disclaimed having ever sold  
Proplast products. Reports of unregistered 'clearinghouse' distributors, mail order advertisements  
and commercial irregularities involving Proplast and Vitek have been received. Two cases  
involving implantation of Proplast-like material to the knee were uncovered in the Québec city  
area incidentally to a study on knee surgery….  
With respect to temporomandibular implants the same document notes, at the same page:  
Adverse events surround the use of Vitek Proplast in the US and a controversy has broken out in  
Louisiana dental surgery circles. The Canadian Dental Association was informed about the  
matter. Complications emerge first in situations involving the temporo mandibular joint (TMJ)  
repair. An investigational Vitek implant claimed to be suitable for insertion during a simple  
office procedures is [sic] presently promoted for mild discomfort and noise incidental to  
movement of the jaw. Such a procedure is evidently gaining popularity in the US but may not  
have reached Canada yet. Major problems are expected if and when and if it does.  
The document from which these quotations are extracted is one of the four the authenticity of which is been  
questioned by the Defendant. For the purposes for which these quotations are used here, I point out only that these  
were implants inserted into the knee and not as temporomandibular joint implants. The two knee implants are  
discussed in a handwritten memo dated September 9, 1982 from P. Blais to Dr. M. T. Cooper (Exhibit 27 v. 1 T. 12  
at p. 000069)  
115 Transcript of Pierre Blais (April 29, 2019) at p. 14 (Dissenter recorded in the transcript as “descenders” which I  
take to be a typographical error.)  
Page: 35  
However, there were [dissenters] who were not within the community, who were  
not within Health and Welfare who occasionally advocated that there were  
potential useful applications for Proplast, but they were not National Health and  
Welfare people.  
[105] Who were they? The quotation immediately above is followed by:  
They were individuals representing manufacturers associations. They were  
individuals who might have presented in connection with a clinical trial, for  
example, the hernia patch issue. There were people who may have been a third  
party or agents acting on behalf of Vitek or Novamed, but these were not people  
from National Health and Welfare. You could deem them to be promoters or  
stakeholders, I think is the word we used, for the product.116  
[106] In other words, they were the people interested in having the product come to market.  
The same people who would have conducted any tests necessary to show that it could be used  
safely and to the advantage of patients who were suffering.  
[107] Can the attitude of Pierre Blais, demonstrated by the broad statements he made, be  
explained or at least a context for understanding be identified? The controversy that surrounded  
his departure from Health and Welfare Canada was not the first time he had run afoul of its  
senior representatives. In April 1981, Pierre Blais was interviewed by a journalist working for  
the Ottawa Citizen in respect of the use of DEHP [“di(2-ethylhexyl) phthalate117] in blood  
transfusion products. He was quoted as saying that “those who give blood through  
plasmapheresis… Could face a long-term risk of kidney or liver injury” and that “the use of  
plastic containing DEHP is a senseless and unnecessary risk”118. Pierre Blais’ comments  
generated considerable consternation among senior officials at Health and Welfare Canada. In a  
memo dated May 4, 1981, addressed to the Director of the Medical Devices Bureau, the Director  
General of the Environmental Health Directorate, Dr. Emanuel Somers, expressed his concerns  
over Dr. Blaisconduct:  
Let me say that I regard Dr. Blais' performance to be alarmist, misleading, and, in  
the final analysis, irresponsible. To elaborate, Dr. Blais is employed as a research  
chemist to study and advise on the physical and chemical properties of  
biomaterials and polymers. He has not the expertise or capability to advise on the  
toxicology of chemical materials. That responsibility rests with the Bureau of  
Chemical Hazards, whose staff comprise a number of experienced toxicologists  
with the required knowledge and abilityOnce again, Dr. Blais is pontificating  
beyond his responsibility or expertise.119  
116 Ibid at p. 14  
117 Agency for Toxic Substances and Disease Registry, Division of Toxicology, Public Health Statement (September  
2002): “A manufactured chemical that is commonly added to plastics to make them flexible.”  
118 Transcript of Pierre Blais (May 13, 2019) at p. 528  
119Ibid at p. 52-528 and Exhibit 34, Tabs 11, 12 and 66  
Page: 36  
[108] There is a memo dated May 4, 1977. It is shown as being from “P. Blais, Materiaux De  
Las Medecine” to “B.N. Thivierge, Chef Division Des Affaires Reglementaires”.120 It is one of  
the four documents the authenticity of which was questioned by the Crown. The document along  
with the other three where the issue was raised was subjected to forensic analysis by experts  
employed by the Canada Border Service Agency in the Analytical and Forensic Services  
Division, Science and Engineering Directorate. I begin by observing that regardless of whether  
the document was “authentic”, which in the context of this case means that it was written on the  
date shown on its face as opposed to sometime later, it would be of little probative value. The  
document asked about the existence of files related to several stated subjects (“Sacs A Sang, Sac  
Pour Parenteraux, I.V., Specimens, Notification”) and asked specifically whether the recipient  
had a recollection of a file named “Silicone Injectable, Polytef and Proplaste”. The reference to  
Proplast in a memorandum asking whether there is a file that includes in its name the word  
Proplast does not help in understanding what was known or not known about material associated  
with that word.  
[109] The work done by the experts does not support a finding that the document was not  
prepared on the date shown, for the purpose stated. The document is not typed. It is  
“handprinted”. It has a handwritten signature above the printed name “P. Blais” and, in the upper  
righthand corner, above the printed letterhead, “MEMORANDUM NOTE DE SERVICE”, it  
has, in handwriting, words identified in evidence as “plastics site”. For the purpose of “Hand  
printing Comparisons” the document is included in the first of two groups of documents being  
examined. The conclusion respecting its authenticity, insofar as the hand printing is concerned,  
was stated as:  
Conclusion: this finding provides more support for the belief that the questioned  
hand printing entries in Group 1 were written during the latter period of the  
specimen hand printing from 1989 or later, rather than on the dates they are  
purported to be produced. However, this support, while greater for the belief that  
the writing is anachronistic than it being contemporary, is limited or weak.  
This comparison was hampered, and the conclusion severely limited, by 1) the  
small amount of specimen writing for the time period after 1989, and 2) the subtle  
and variable nature of the features upon which the assessment is based which  
creates significant uncertainty in the final conclusion.121  
[Emphasis added]  
[110] This document is dominated by the hand printing. Even so the experts go on to examine  
the signature found above the hand printed “P. Blais”. Under the heading “Signature  
Comparisons” this signature is dealt with in the second of two groups. The conclusion is as  
follows:  
120 Exhibit 27 T. 2 and Exhibit 73 T. 3  
121 Exhibit 74A (Forensic Laboratory Report 27 February 2019) at p. 37 of 84  
Page: 37  
Conclusion: This finding provides support for the belief that the questioned  
signatures on Items Q1 [the document presently being considered]…were written  
during the latter time period of the specimen signatures (2000 and after), rather  
than in the time period of the earlier specimen signatures (1966-1991). The level  
of support is considered to be strong.  
The comparison and the conclusion were limited somewhat by the relatively small  
amount of specimen material provided for the timeframe after 1991.122  
[Emphasis added]  
[111] To place the noted concern (being the small number of specimens available for the period  
after 1991) in context, the number of specimens relied on for the identified period are: two from  
1991, one from 2000, one from 2005 and three from 2018. To put it differently, “After 1991” but  
before 2018 there are only two specimens. The three from 2018 are all signatures by which  
Pierre Blais swore to the accuracy of three affidavits that bear his name. The expert  
acknowledged that this is an unusual circumstance. It is one which may lead a party to be more  
attentive of the act of signing.  
[112] The question being asked is a serious one. It is about the fundamental integrity of the  
individual involved. I am not prepared to find, on a balance of probabilities, that this document is  
anything other than what it appears to be.  
[113] I feel obliged to make a further observation. This is not the only one of the four  
documents being questioned which has little if any probative value in respect of the issues raised  
in this case. None of them do. From this, one has to wonder why the Crown felt compelled to  
continue with the issue of their authenticity. I asked about the purpose. The first time the  
question was asked, counsel indicated concern for what this might say about the integrity of  
Pierre Blais. When the issue arose again the Court was advised that there is a separate  
application brought by the Plaintiff by which her counsel seeks to demonstrate that the Crown  
destroyed documents presumably knowing them to be relevant to this case. Counsel for the  
Crown expressed the view that any decision made in these reasons respecting this issue could  
impact that further application. To the extent that the rationale for the inquiry into the  
authenticity of these documents is the impact these reasons may have on a further application, it  
is collateral to the matters of concern in this trial. If it is the only true purpose, it is improper. The  
issue of the destruction of documents is not before the Court. To my mind, any findings made  
here should not be taken as determinative of issues to be raised after what would be a more  
complete evidentiary investigation specifically directed to those questions.  
[114] There was some confusion as to what exactly Pierre Blais did upon his return from the  
Gordon Conference. In an affidavit he swore on January 16, 2000 he deposed that “after my  
122 Ibid at p. 38 of 84  
Page: 38  
return to Canada I wrote a proposal recommending the prohibition against materials like  
Proplast/Vitek.” In this affidavit Pierre Blais goes on to say that he took his recommendation that  
Proplast be prohibited to his superior, Dr. Ron W. Campbell, that “to the best of [his]  
information knowledge and belief” Dr. Ron W. Campbell passed the recommendation on to the  
Director of the Medical Devices Bureau, Dr. Ajit K. DasGupta, that on the same basis he  
understands that Dr. Ajit K. DasGupta agreed with the recommendation and passed it on to Dr.  
Emmanuel Somers, who according to the information, knowledge and belief of Pierre Blais  
rejected the proposal. There is no document that would support this recollection. The Rules of  
Civil Procedure, at the time this affidavit was sworn, as they do now, required that when a fact is  
attested to on “information and belief” the source of that asserted knowledge is to be  
“specified”123 It was not. The affidavit goes on:  
The reasons for my proposal were included in the written material, which was part  
of a Bureau proposal for amending the Medical Devices Regulations.  
[115] There is a document directed to amending the regulations. It is entitled “A Need for  
Enhanced Regulatory Control of Invasive Medical Devices.”124 It first appears in company with  
a covering memo dated May 28, 1981.125 It does not mention the prohibition of Proplast  
products. In cross-examination counsel tried to clarify the uncertainty. Counsel suggested that  
the proposal for prohibition must be in some other document and Pierre Blais answered:  
Q. So that, this, I take it, sir, is a different, because of the timing, a different  
proposal or recommendation that you wroteThat's a different one than the one  
we looked at that's dated, that's at Exhibit 27, tab 7, from 1981. This is a different  
one. Is that right?  
A. It -- what you're referring to is probably the first ancestor to the series of  
memoranda of which you have one, what we have called the 1981 memorandum.  
The -- there was -- we discussed a few minutes ago my preparation of documents  
for Dr. Campbell to brief his superior, and it did -- that was the very first of the  
documents which ultimately led to many others, including the last one on  
ophthalmic products. It was the first ancestor.126  
[116] There is no series of documents as referred to. The one that was produced does refer back  
to the Gordon Conference albeit five years later, as of May 28, 1981:  
During the late seventies, Dr. Homsy and his associates made numerous  
conference presentations and published a series of papers presenting Proplast  
applications and the outcome of clinical studies. All conveyed information which  
seemed contrary to basic medical and scientific principles. The findings also had  
promotional overtones and were met with scepticism [sic]. At a 1977 conference  
123 Rules of Civil Procedure R.R.O. 1990, Reg. 194 at R. 39.01(4) and (5)  
124 Exhibit 27 v. 1 T.7 and T. 11, Exhibit 34 v. II T. 84 and Exhibit 73 T. 4  
125 Exhibit 27 v. 1 T. 7 and 73 T. 4  
126 Transcript of Pierre Blais (May 10, 2019) at p. 479  
Page: 39  
of assembled biomedical leaders, pathologists and regulatory affairs specialists,  
Dr. Homsy’s presentation was savaged by members of the audience.127  
[117] The document does not propose the prohibition of Proplast or similar products. Rather it  
proposes the following:  
In light of the present information, all Vitek, Proplast and Proplast-like implants  
should be placed in a special category subject to close supervision by hospital or  
professional ethics committees. If adverse events continue to be reported, the  
product should be sequestered by the field operations directorate until the  
regulatory status is clarified. A similar caveat should apply to any medical  
implant based on graphite, glass or other high-performance fibers with or without  
a consolidating matrix substance.128  
[118] Pierre Blais said, in his evidence, that this document was prepared as part of submissions  
to be made to Treasury Board. This is confirmed by the covering of memo:  
PLASTIC FLUID HANDLING SYSTEMS AND IMPLANTED DEVICES  
Rationale for regulatory amendments  
Following our discussions with Dr. DasGupta, I have updated the Divisions  
rationale for regulatory amendments for our next Project Review.  
As requested, I have added a discussion on countermeasures and regulatory  
options. Expanded briefings can be drafted for TB [Treasury Board] submissions.  
[119] The document appears more than once. Not only is it presented as of May 28, 1981, it  
and the memorandum which encloses it, reappear. On the second version the typed date “May 28  
1981” is struck out and replaced in handwriting by the date “Feb. 18, 82.” As explained by Pierre  
Blais the document was used twice to assist in the preparation of the annual submission made to  
the Treasury Board on behalf of the Bureau.129 The second version has a further handwritten note  
asking “Linda” to have the file printed with large type “for Dr. DasGupta’s TB sub”.130  
[120] These submissions produced a positive result. They led to the amendments to the Medical  
Devices Regulations that added to the Schedule to Part V any “new device” designed to be  
implanted into the tissues or body cavities of a person for 30 days or more. As already noted, the  
amendment was made on October 8, 1982 and became effective on April 1, 1983. Following a  
review of the document I asked and Pierre Blais responded:  
127 Exhibit 27 v. 1 T.7 and T. 11, Exhibit 34 v. II T. 84 and Exhibit 73 T. 4 at p. 13. There was some confusion as to  
whether the Gordon Conference took place in 1976 or 1977. In the end, despite what was said here, it was  
determined to have been held in 1976.  
128 Ibid at p. 14  
129 Transcript of Pierre Blais (May 2, 2019) at p. 25-26  
130 Exhibit 27 v. 1 T. 11, Exhibit 34 v. II T. 84 and Exhibit 73 T. 4  
Page: 40  
THE COURT: All right. Now, looking not backwards from that but looking  
forwards to where this went ultimately, ultimately, if I understand this correctly,  
all of this concern leads in the end to the amendment in the regulation Part V in  
1983, in which now we see these kinds of implants, implants that are going to be  
input and last for more than 30 [days], becomes part of Part V.  
A. Exactly.131  
[121] As it turned out, these three documents, the two versions of the covering memorandum  
and the paper, “A Need for Enhanced Regulatory Control of Invasive Medical Devices” are the  
second set of documents where the authenticity is challenged. The primary concern with the  
paper arises not from handwriting or hand printing but from the type face used. In the early  
1980’s modern office machines were beginning to appear. However, Health and Welfare  
Canada, as most offices of the day, still used typewriters. This was determined by a review of  
documents produced at the time. Typewriters are distinguishable from more modern machinery  
as impact printers: the paper is struck by a letter either on an arm or ball. Typewriters utilized  
“mono spaced” print. The letters, regardless of their form, take up the same width. The letter “m”  
takes up the same space as the letter “i”.132 More modern office machines use “proportional  
spaced” print. The width of the letters varies.133 The printing on the documents was  
proportionally spaced. The type face (font) was identified as Helvetica which had existed since  
1961 and was based on designs that go back to 1957.134 This design was not seen on any known  
documents with typewritten entries at Health and Welfare Canada.135 Glyphs (described as  
“TM”  
“R”  
letter/character design) for example  
and  
were observed to be different from those of  
Helvetica and other similar versions. The experts from the Canada Border Service Agency  
concluded:  
A Helvetica style of typeface was not seen on any known documents with  
typewritten entries at Health and Welfare Canada.136  
[122] They went a step further; they searched typewriter databases to see whether the typescript  
on the documents in question could be found in any proportional spacing typewriter. Such  
spacing was not common in typewriters at the time. No typeface in any of the identified  
classification systems were observed that corresponded to the typed entries being examined. The  
glyphs “TM” and “R” were not commonly available in any typewriters from the time.137 The experts  
found that:  
131 Transcript of Pierre Blais (May 10, 2019) at p. 483-484  
132 Exhibit 74A (Forensic Laboratory Report 27 February 2019) at p. 58 of 84  
133 Ibid at p. 59 of 84  
134 Ibid at p. 18 of 84  
135 Ibid at p. 19 of 84  
136 Ibid p. 19 of 84  
137 Ibid at p. 19 of 84  
Page: 41  
Accordingly, no features were observed to indicate that the typed entries depicted  
on documents Q2 (1-22) were produced on any typewriter, at Health and Welfare  
Canada or available elsewhere, in the time period in question.138  
[123] The forensic experts also examined the handwriting that appeared on the covering  
memorandum. This includes the note asking “Linda” to print the document in larger script, the  
handprinted date and the signature “P. Blais”. In each case the determination is the same. The  
script tends to be consistent with the specimens of the date shown on the document: it is  
“contemporary” rather than “anachronistic”. Thus, these results are different than those  
associated with the typed script. However, as a result of the lack of later specimens from the later  
time frame the experts do not foreclose the possibility that the hand writing was nonetheless  
from a later date than shown on the face of the document.139  
[124] Obviously, this leaves the situation confused. The handwritten and printed script tends to  
the documents being contemporary and the typed script to a later anachronistic date. The experts  
acknowledged that while at the contemporary time the typed script was unlikely to have been  
produced by a typewriter, there were “commercial printers” that were capable of producing the  
script used. Work they had done to establish the equipment utilized by Health and Welfare  
Canada, at the time contemporaneous to the dates shown on the face of the covering memoranda,  
provided no indication that there was machinery available from contractors involved, who might  
have had access to printers with the capacity to produce the script used.  
[125] Although not a party to the action, Pierre Blais was examined for discovery. In the course  
of this questioning Pierre Blais alluded to the possibility of the printing of these documents  
having been done out of the normal context:  
In 1982 the printing that you see in your hand is an alien printing. It comes from a  
contractor or a machine that was not familiar to me. It was a wizardry of a  
computer specialist who essentially reprocessed obsolete medium in order to  
extract the original text.  
[126] During that examination Pierre Blais referred to a company that he said had a contract  
with what was then Health and Welfare Canada “for our word processing system”:  
They produced software…and they produced customize systems for correlative  
data at National Health and Welfare, and probably other departments as well.  
They also did some kind of service on printers. And, they periodically, I think,  
loaned us printers, including kinds that I’ve never seen before.140  
138 Ibid at p. 19 of 84  
139 Ibid at pp. 35-36, 37 and 38 of 84  
140 Transcript of the Examination for Discovery of Pierre Blais (February 5, 2019) at pp. 210-212  
Page: 42  
[127] Counsel for the Crown was quick to point out that, in the absence of the ability to cross-  
examine Pierre Blais on these matters this evidence was, at best, hearsay.141 However, the  
question was not whether it should be accepted for its truth but whether it stood as a suggestion  
the experts were aware of as they undertook their work. The forensic expert providing this  
evidence was Tobin A. Tanaka. He had read some transcripts before coming to his conclusions.  
It was his recollection that he had read of the individuals named in the transcript as associated  
with the suggestion that an outside printer could have been involved. Neither he nor the other  
expert, R. Brent Ostrum, had conducted any further investigation into this possibility. It was  
beyond their mandate. Their concern was as to the physical properties of the documents not their  
source, context or content.  
[128] If I were required to do so, I would on a balance of probabilities, conclude that these  
documents are authentic, that is they are as they appear. The main document “A Need for  
Enhanced Regulatory Control of Invasive Medical Devices” is comprehensive dealing with far  
more than just Proplast products. Pierre Blais proposed that there were many more versions but  
there are only two that appear in the record (1981 and 1982). The two are consistent with the  
stated purpose of assisting in demonstrating to Treasury Board that more was required to  
properly regulate medical devices. This was apparent from both the overall subject matter and  
the timing leading, as it does, to the amendments made on October 8, 1982 and made effective as  
of April 1, 1983.  
[129] As it is, the value of these documents as providing information supporting a position that  
the accepted knowledge about Proplast was such that it should have led inexorably to a  
conclusion that products using Proplast should never have been allowed into the market is  
minimal if it exists at all. Why is this? It is because Pierre Blais, for all that he is relied on as the  
beacon of this idea, acknowledged that amendments to the Medical Devices Regulations that  
added implants that were to stay in the body for 30 days to those to be treated under Part V of  
those Regulations was a sufficient response to the issues as he saw them. There is no document  
demonstrating that a prohibition was ever asked for.142 There was no need for an absolute  
prohibition whether or not one was ever proposed:  
THE COURT: And I thought it was -- and you didn't say this before. I just sort  
of remembered it when I was trying to work out in my own mind something that  
you said. Remember that you said: When we ask for things, I dream; I ask for  
everything that I could possibly want, and sometimes all I get is what I need. Do  
you remember that?  
A. Yes.  
THE COURT: And I thought that maybe this fits that understanding of how this  
works: You asked for a prohibition, didn't get it but got what you needed because  
you got to examine the safety and efficacy of it?  
141 One of the people referred to “Barbara Goldhamer” was identified by Pierre Blais in his viva voce evidence albeit  
for a different purpose (Transcript of Pierre Blais (May 1, 2019) at pp. 100-101)  
142 Transcript of Pierre Blais (May 10, 2019) at p. 484  
Page: 43  
A. Yes. It was time when we accepted reality.143  
[130] In fact, it was what he had proposed in the document entitled “A Need for Enhanced  
Regulatory Control of Invasive Medical Devices”:  
Regulation Amendments are Inevitable  
The present medical devices regulations enable inclusion of supplemental device  
categories to the list of ‘high risk’ products. Accordingly, case-by-case addition of  
specific product categories that embody risks at par or greater than those of the  
present classes subject to the provisions of Part V. A timetable setting the date  
when each of the new categories become subject to the new requirements would  
then be proposed for comment by industry and consumer representatives.  
Alternatively, a new set of classification criteria for devices subject to Part V  
requirements could be created. It is noteworthy that all, except one, device classes  
presently comprised under terms of Part V are implants. …  
[131] This was followed by a proposal for the classes of devices that could be added to Part V.  
The first of which was:  
Missing Major Classes  
All of the presently-listed Part V device categories and most classical implants of  
other types would be captured under the term “implant”. Thus, a device intended  
to be inserted in tissue or a body cavity or expected to be in intimate body contact  
for an indeterminate period would become subject to the provisions of Part V. The  
issue of contact time is moot. A large body of research and retrospective clinical  
studies have demonstrated that direct contact with a faulty device for about a  
month is sufficient to impart severe damage to user exposed to an injurious device  
that does not have an essential physiologic or mechanical function. The presently  
cited “30 day” watershed exposure would thus be retained.144  
[132] This offered the public a level of protection:  
THE COURT: Okay, just a minute. So dreaming or dreams includes the  
understanding that there would always be a limit on what the regulations would  
allow, which I take to mean that there was an acknowledgment that there were  
other considerations that regulators would bring to bear on the question which  
would probably mean you would not get exactly what you wanted in terms of  
regulatory power.  
A. Yes, absolutely correct.  
143 Transcript of Pierre Blais (May 13, 2019) at p. 633  
144 Exhibit 27 v. 1 T.7 and T. 11, Exhibit 34 v. II T. 84 and Exhibit 73 T. 4 at p. 2  
Page: 44  
THE COURT: All right. And then what you needed was for what you said was  
minimal protection, therefore it was something less than the dream, but something  
that would provide you with some level of regulatory authority to provide for  
some level of protection to the public.  
A. Yes.145  
[133] It was a compromise:  
THE COURT: Okay, from which I deduced that -- and I'm asking now -- that  
what we have here, as you have now described it, is an appearance of a concern,  
the evolution of that concern into fear, and a process by which the various  
competing points of view worked, ultimately winding up at what you've called a  
compromise, which was, in effect, the 1983 inclusion of the 30-day rule, which  
would have taken in Proplast and any consideration of it?  
A. Exactly.146  
[134] Pierre Blais acknowledged this was typical of how amendments to regulations came to  
be. He was asked:  
THE COURT: So I want to say again and make sure I have this established with  
you, that this is something you understood at the time, that this was a typical  
evolution of a regulatory change.  
A. Exactly147  
[135] This is not evidence that demonstrates a dedication to the prohibition of Proplast products  
but rather the expression of concern, the acceptance of that concern and, in time, the arrival at  
what was accepted as an appropriate regulatory response.  
[136] The document (“A Need for Enhanced Regulatory Control of Invasive Medical Devices”)  
was put to Janice Hopkins. She had been employed at Health and Welfare Canada from 1969 to  
1979. She left and went to the Department of Fisheries and Oceans. She returned during 1980 as  
the Director, Atlantic Region (Halifax). From 1982 to 1985 she was the Director of Management  
Processes working in the Assistant Deputy Minister’s office. She was responsible for, among  
other things, how resources were allocated. She and her staff provided the rationale to be put to  
Treasury Board for the requests being made. Janice Hopkins does not recall the document (“A  
Need for Enhanced Regulatory Control of Invasive Medical Devices”). It needs to be  
remembered that she only returned to Ottawa during 1982. More importantly, the evidence  
provided by Janice Hopkins confirms the thrust of that paper to the effect that more resources  
were required to properly regulate medical devices and their entry into the market in Canada. She  
145 Transcript of Pierre Blais (May 1, 2019) at p. 20  
146 Transcript of Pierre Blais (May 10, 2019) at p. 486  
147 Transcript of Pierre Blais (May 14, 2019) pp. 632-633  
Page: 45  
identified the minutes of a meeting of the Cabinet Committee on Social Development held on  
March 4, 1981, prior to her moving to Ottawa in 1982.148 Apart from the members of Cabinet,  
staff from several of the interested government departments were present. This included four  
people from Health and Welfare Canada including “Mr. E. Somers” who Pierre Blais said turned  
back his recommendation that Proplast be prohibited.  
[137] The Committee had for consideration a Memorandum dated February 3, 1981 and  
Discussion Paper of the same date, submitted by the Minister of National Health and Welfare,  
recommending increased resources for the Medical Devices Program to permit it to more  
adequately carry out its responsibilities under the Food and Drugs Act.149 The Minister of  
National Health and Welfare opened the discussion. She began by…  
… answering a question posed earlier by the Ministry of State for Social  
Development regarding other options for dealing with the problem of regulating  
the safety and efficacy of imported medical devices. She explained that her  
department already uses information from United States regulatory agencies, the  
Canadian Standards Council and other reliable agencies but that this alone is  
inadequate for improving controls to the necessary level. The proposed approach  
is sufficient to deal with the most dangerous devices and usage abuses, but given  
the very large number of devices imported from over 30 countries, the rapid rate  
of technological change and the sophistication of the technology, it will always be  
impossible to check every device type. The provinces help to some degree by  
certifying use of certain devices within their territory, but sharing of the work of  
testing devices and setting standards could result in fragmented standards and a  
fragmented market. She asked to be excused from the study of options requested  
by the ministry, since she is satisfied that there are no practical options and that  
the only means of reducing expenditures would be to impose a user fee. This  
could increase healthcare costs.150  
[138] The Discussion Paper under the heading “RECAPITULATION” summarized the  
recommendation being made:  
The main points raised in the foregoing are:  
Medical devices are essential for modern healthcare but many sold in Canada are  
hazardous or ineffective and cause avoidable health or injury.  
The Department of National Health and Welfare is responsible under the Food  
and Drugs Act for ensuring that manufacturers sell only safe and effective  
devices.  
148 Exhibit 55 at T. 3  
149 Ibid at T. 3, p. 15 and respectively at T. 1 and T.2  
150 Ibid at T. 3, p. 15-16  
Page: 46  
The Department is unable to fulfil this responsibility adequately with present  
resources.  
Regulatory control of devices in Canada must cope with the unusual situation  
arising from the lack of domestic manufacturing the high dependence and demand  
for technology by the healthcare delivery system.  
A collaborative strategy involving the government, manufacturers and users,  
tailored for the Canadian situation, is proposed. This requires 20 PY [person  
years] in 1981-82 and an additional 14 PY in the following year for a total of 34  
PY to:  
(a)  
(b)  
(c)  
Ensure reasonable probability of safety and effectiveness of the  
highest priority inventions before open marketing;  
develop essential performance and safety standards and testing  
capability; and  
take corrective and preventive actions in response to report of the  
most severe device failures.151  
[139] The proposal for a collaborative strategy involving the government, manufacturers and  
users was accepted. The Record of Cabinet Decision, dated December 8, 1981, noted:  
8. Medical Devices Program  
(1) the proposal be approved but the question of additional person years be  
considered by the Treasury Board;  
(2) the Minister of National Health and Welfare be requested to develop an  
overall policy on the question of allocation of costs in relation to testing the safety  
of drugs and devices and to report back to the Committee within a year.152  
[140] The need for additional person years was recognized, the costs acknowledged but  
approved. The approval was explained in a letter to the Deputy Minister dated February 24,  
1982:  
Dear Mr. Fry:  
Your minister’s submission seeking resources for an expanded program testing  
and evaluation of medical devices was re-considered by the Treasury Board on  
February 11, 1982. In addition to the approvals given by the Treasury Board at its  
151 Ibid at T. 2 (Discussion Paper) at pp. 21 and 22  
152 Ibid at T. 4 (Record of Cabinet Decision) at p. 5  
Page: 47  
meeting of July 23, 1981, as contained in my letter of July 30, 1981, Ministers  
approved the following:  
(a)  
inclusion of an item in Supplementary Estimates 1982-83 of 20 person-  
years and associated salaries of $503,000 for the medical devices program;  
and  
(b)  
an increase in your departments reference levels of 34 person-years and  
associated salaries of $855,000 in 1983-84 and subsequent years.  
Ministers requested the department to report to the Treasury Board no later than  
January 1984 on the appropriate level of service for the medical devices program,  
based on information available at the time.  
Yours sincerely,153  
[141] This approach and these considerations demonstrate a recognition of the concerns  
associated with the regulation of medical devices. These actions were a substantial effort to  
adjust the approach and provide appropriate resources not just with respect to Proplast products  
but the broader concern for medical devices at large. This is consistent with the document “A  
Need for Enhanced Regulatory Control of Invasive Medical Devices” the content of which went  
beyond concern for a single product type and proposed solutions within the regulatory scheme as  
opposed to an absolute prohibition of Proplast products. With the October 8, 1982 amendments  
in place, the regulatory approach can be seen as collaborative. It relies on:  
the manufacturers and distributors to undertake the necessary testing,  
the government to consider whether, based on the information provided, a  
reasonable probability of safety and efficacy has been demonstrated for the  
highest priority inventions (i.e. those to which Part V apply), and  
users (doctors, hospitals and patients) to report on difficulties that may appear.  
[142] The decision to adopt a collaborative approach was an important one, made at a crucial  
moment in the evolution of the policy governing the treatment of medical devices. It is a decision  
that informed, modified and explains what happened thereafter in connection with the regulation  
and regulatory activity that affected this area of concern.  
[143] Those efforts did not stop with those amendments becoming effective as of April 1, 1983.  
The record of this trial includes a document dated February 1985, entitled:” Medical Devices  
Program, Health Protection Branch, Department of Health and Welfare, Workload Submission”.  
It is a proposal to obtain approval to include in the 1985-1986 Supplementary Estimates  
153 Ibid at T. 6  
Page: 48  
increased funding to allow delivery of the approved minimum level of service for the Medical  
Devices Program.154  
[144] This is not to say that over time, from time to time, government demands did not require  
adjustment to the resources made available. A letter dated September 26, 1985, from the Minister  
of Health and Welfare Canada to the President of the Treasury Board is a case in point. It does  
not deal specifically with medical devices. It reads in part:  
The updated Multi-Year Operational Plan for my Department is being forwarded  
to the Treasury Board Secretariat. As requested this plan incorporates our detailed  
proposals for reducing our person-year (PY) requirements over the next five-year.  
To achieve the targets proposed to us by the Treasury Board Secretariat.  
As will be seen in the detailed plan, we have been able to identify a variety of  
person-year reductions which will enable us to meet our targets. Indeed, we have  
identified possibilities for PY reductions which are considerably in excess of our  
targets.  
[145] The same letter maintains the concern of the ability of Health and Welfare Canada to  
have the resources necessary to undertake its responsibilities:  
The MYOP also identifies those areas where we require additional resources to  
meet unavoidable workload increases, to carry out new governmental decisions,  
and to cover increases in the costs of maintaining a non-discretionary level of  
service.  
However, I do have to put on the record the fact that I am able to offer reductions  
of this magnitude only on the understanding that new resources would be made  
available to enable me and my Department to meet essential requirements for  
which there is no provision in current reference levels, whether these arise from  
new government decisions or from unavoidable workload increases. Without this  
understanding, clearly I could not make all these cut-backs from departmental  
person-year resources, because it would become essential for me to divert  
resources to other requirements.155  
[146] This followed a one-person year cut imposed on the Environmental Health Directorate of  
which the Bureau of Medical Devices was part, effective April 1, 1984. Of this a 0.33 PY cut  
was allocated to the Bureau. At the same time a similar cut of 0.33 PY “temporarily” for the last  
154 Ibid at T. 9  
155 Ibid at T. 13  
Page: 49  
few months of 1983-1984 was extended indefinitely.156 To my mind, these are small changes  
made in response to policy adjustments that mark the constant evolution of government  
priorities. They do not signify any change in the commitment to, or inadequate support for, the  
regulation of medical devices.  
[147] Through the early 1980’s the regulatory scheme was amended to meet the challenge  
posed by the increased interest in, development of and demand for medical devices. The  
changes, while not what Pierre Blais says he “dreamed of” as the response to products that  
included Proplast, were sufficient to allow for protection of the public. What was the general  
understanding of the utility of Proplast and the medical devices in which it was included? It was  
not universal acceptance that it was dangerous or that any harm associated with it outweighed  
any benefit. In 1983 a book was published157: “Biomaterials in Reconstructive Surgery.” The  
book was edited by Dr. Leonard R. Rubin. Some of his credentials are listed on fronting page of  
the book: for example, “Diplomate, American Board of Plastic Surgery; Clinical Professor,  
Plastic Surgery, State University of New York, Stony Brook and Director, Plastic [and]  
Maxillofacial Surgery and Burn Center, Nassau County Medical Center, East Meadow.158 The  
book was described by Pierre Blais as a “teaching textbook on plastic surgery.159  
[148] Pierre Blais explained to the Court that he had worked with Leonard R. Rubin at the  
facilities of the State University of New York in relation to a Proplast chin implant.160 He said  
that work demonstrated that part of the Proplast implants had disintegrated and scattered over  
about a half-inch of tissue. The implant was surrounded by a layer of pus.161 This information  
was conveyed to his superiors at Health and Welfare Canada “between ‘79 and ’80;”162 which is  
to say years before the book was published and before the amendment to the Medical Devices  
Regulations which added these implants to those devices being treated by Part V.  
[149] Leonard Rubin is shown as the author of Chapter 30 of the book, the chapter in which the  
work of Pierre Blais is reviewed.163 It refers to the observation of two patients with mandibular  
implants: one placed for 32 years the other for 18 years. These were the tissues evaluated by  
156 Ibid at T. 9, p. 6  
157 Pierre Blais first testified that the book was published in 1981 (Transcript of Pierre Blais (May 1, 2019) at p. 98)  
but the book itself bears the date 1983 (Exhibit 34 v. 1 T. 17 and T. 19) and Pierre Blias subsequently agreed it was  
published in 1983 (Transcript of Pierre Blais (May 3, 2019) at p. 404)  
158 The complete list found on the fronting page includes: “Attending Plastic Surgeon, Nassau Hospital, Mineola and  
Mercy Hospital, Rockville Centre; Honorary Plastic Surgeon, North Shore University Hospital, Manhasset, New  
York [and] 1978 Chairman of Gordon Research Conference in Biomaterials.”  
159 Transcript of Pierre Blais (May 1, 2019) at p. 98  
160 Transcript of Pierre Blais (May 3, 2019) at pp. 399-400  
161 Ibid at p. 401  
162 Ibid at p. 402  
163 Exhibit 34 v. II T. 98  
Page: 50  
Pierre Blais. The implants used polyethylene, not Proplast. Pierre Blais acknowledged the work  
he did, that is reported in the book, does not consider any Proplast product.164  
[150] To the contrary, insofar as Proplast is concerned, the book suggests something quite  
different.  
[151] Chapter 31 of the book is entitled “Clinical uses of Proplast: expectations and results”  
Pierre Blais said he reviewed the chapter and prepared a critique. He “may have” a copy it but it  
was not produced.165 The results of the studies reported in this chapter include:  
The extensive amount of experimental animal studies that preceded its use in  
humans included the usual small laboratory animals as well as canine and primate  
implantations, which later were followed in a few cases much longer than the  
usual [illegible] period under the direction of the original experimenters who  
continued their observations to their clinical usages. The continued clinical  
observation of the implants has allowed interim biopsies, which were quite  
desirable. A collation of a total series reported to the manufacturer’s lead to a  
review of a series of 900 clinical implantations with the rejection rate of less than  
2%.166  
Our histological review of these implants and their capsules have shown that all  
the implants are surrounded by pore spaces invaded by multinucleated giant cells.  
However, we have noted that the population of the giant cells seemed to diminish  
with prolonged fibrous tissue in growth though this is based on segmental  
biopsies of clinical patients rather than total removal of the implant and its  
surrounding tissue reaction for study. Nonetheless, in a few patients because of  
gross irregularity or too large a prosthesis, large sections were removed and  
studied after several years of insertion and they confirmed the experimental  
findings in those primates studied for a period from 3 to 5 years-firm in growth  
with adequate fixation.167  
Surface fragmentation  
There is surface fragmentation, and when the material is examined under a  
microscope (Fig. 31-4), one would expect this of a fiber-felt multi-open pored  
implant. Bits of surface fragmentation have been found as inclusions in  
multinuclear giant cells (Fig. 31-5) nonetheless, the implants have clinically  
164 Transcript of Pierre Blais (May 3, 2019) at pp. 409-410  
165 Exhibit 34 v. I T. 19  
166 Transcript of Pierre Blais (May 13, 2019) at p. 585  
167 Exhibit 34 v. I T 19 at pp. 494-495  
Page: 51  
maintained the initial contour with no clinically palpable detection of the minimal  
fragmentation or migration of material. Darkening of the skin, in superficial  
locations, such as the nose, the periorbital region, or any area with scar covering  
or thin overlying skin with little subcutaneous tissue, by black phagocytized  
material has appeared in the dermis can be progressive. This is believed to be a  
significant problem in and around the thin tissues and after superficial removal  
reoccurrence has been noted, requiring not only the substitution of the Proplast I  
with other materials but also, on two occasions, resection of the surface covering.  
The migration of material has [illegible] sufficiently serious around the nose and  
the periorbital region and one chin to necessitate total removal of implant and its  
surrounding fibrous tissue and its initial replacement with either a dermis or  
superficial that flap followed at a later date by implementation of other  
material….168  
SURVEY OF CLINICAL USAGES  
The clinical experience over the past 10 years has been reviewed in an ongoing  
accomplice and report on more than 900 human implantations with Proplast I that  
were carried out internationally by surgeons of various backgrounds using varying  
techniques and with varied methods of implant and recipient site preparation. The  
use of the implant material was preceded by a 5-year intensive experimental study  
of the biocompatibility of Proplast varying anatomic areas and many different  
animals, from mice to primates, as well as continuing and repeated studies  
biocompatibility in with tissue cultures. In 1973, “The Clinical Use of a New  
Porous Implant: Proplast”,” a review of a five-year serial studies of this material  
in baboons, was presented to the Association of Plastic Surgeons. In 1975 a 4-  
year ongoing clinical study of human Proplast implantations included alveolar and  
maxillary augmentation, coating of self-stabilizing condylar prostheses,  
mandibular augmentation, soft tissue replacement and reconstruction of costal,  
sternal, facial and cranial bone deformities. A survey conducted by Kent et al.,  
presented at the International Biomaterials Congress in April 1980, reviewed 700  
patients and demonstrated “immediate and delayed” success rates well in excess  
of 90%. The literature of the past few years contains reports by experienced  
plastic surgeons, maxillofacial surgeons, otolaryngological surgeons, oral  
surgeons, and even ophthalmological surgeons, as to the uses and proposed use of  
Proplast I. Although all the ophthalmological clinical trials were experimental,  
Proplast was well tolerated as implants in the cornea and skilled era and obviously  
a good deal has yet to be studied, including the rate of post-tissue in growth in the  
long-term acceptance of the alloplast….169  
168 Ibid at pp. 498-501  
169 Ibid at p. 501  
Page: 52  
SUMMARY  
Proplast has fulfilled to a large degree the criteria that were planned in its original  
development; it has a minimal reactivity and is thermostable, and the surface  
porosity allows penetration by the adjacent fibroblasts and a certain amount of  
tissue fixation. Although relatively easy to shape, there are problems involved  
with irregularities, possible feathering of edges, which may, at a later date, flare.  
But its low elastic modulus is sufficient to allow gentle massage and external  
compression though direct incision and revision of the implant has been carried  
out. Except for the one case mentioned, our incidents of infection has been  
extremely low. We have had implants that have developed seromas around the  
larger sections, possibly because of rib-cage motion during breathing but  
eventually tissue fixation has been excellent. We have not seen fixation correlate  
with deep penetration, nor have we seen even the long-term cases show a good  
bony scaffold. There has been a tendency to fragmentation of the surface with  
encapsulation of particles by macrophages, which seem to have migrated to the  
dermis. To date this has only been apparent in the superficial dictations below thin  
skin flaps or adjacent thin scars. It may be that the light-colored Proplast II may  
satisfactorily eliminate this problem, but a further long-term follow-up study is  
necessary….170  
[152] This chapter and the studies to which it refers do not confirm that by the early 1980s  
there was an understood and comprehensive conclusion that any harm caused by the  
implantation of Proplast products would inexorably outweigh the benefits that could be achieved.  
[153] The chapter in which this appears was written by Charles Homsy, the developer of  
Proplast. Given his expressed concerns, Pierre Blais was asked why the editors of the book (he  
was one of them) decided the chapter was worthy of inclusion. The reason? Maybe Charles  
Homsy was right:  
…collectively in consensus, we decided to err using the logic that was presented  
by His Honour. We reasoned: What if Charles Homsy were right; therefore give  
him a springboard or maybe a point to express his views and let the rest take place  
as it should. We left it to the reader to decide for themselves. That was the  
consensus.  
THE COURT: But it raises the prospect that it was still believed by the group as a  
whole, maybe not all the individual members, that it was still possible that Homsy  
was right.  
170 Ibid at pp. 507-508  
Page: 53  
A. Yes.171  
[154] According to Pierre Blais this happened well before the book was published. The  
decision was taken in 1979, still after the furor Pierre Blais says took place, at the Gordon  
conference, in opposition to Charles Homsy.  
[155] Dr. Doran Ryan is an American maxillofacial surgeon. He is a teacher and frequent  
speaker on the subject. Doran Ryan provided evidence as to the history of the effort to deal with  
problems associated with the temporomandibular joint. 1982 was a significant year. There were  
advances in the applicable radiology. It had not been possible to inject dye into an area as small  
as the temporomandibular joint. This became feasible in 1982 making it easier to identify the  
kind of problems involved. Prior to this advance it was difficult to identify the problem when  
patients complained of pain or discomfort. In some cases, it was thought to be purely  
psychological. In others, more conservative treatment was used: muscle relaxants, anti-  
inflammatory drugs, painkillers and other areas of expertise such as neurology. Even with the  
improved imaging these “modalities” were still used. Some surgical treatments were undertaken.  
Doran Ryan referred to “Dr. Brown” who was taking out the meniscus with a high degree of  
success. He had about a 20% failure rate. Beginning in or around 1963, surgeries were  
undertaken, where part of the bone was removed and replaced with a block of solid silicone  
(described as “gap arthroplasty with implant”). In 1980, efforts were made to reposition the disc.  
When it became apparent that repositioning the disc, after displacement, was not always  
possible, the disc was removed and solid silicone sheeting used as a replacement. This was  
expected to last for years. However, silicone did not have sufficient strength and tended to tear.  
A different solution was needed.  
[156] As reported by Doran Ryan, the first published results regarding Vitek Proplast Block as  
an interpositional implant appeared in 1982, when for example Kiersch reported a 93% success  
rate over nine years for 250 implants:172  
No, no. Vitek did the studies. They have files, a mechanical engineer that did  
those studies, and that's what they had. And they also had -- by the time I used  
that product in [1983],173 they already had nine years of experience implanted in  
the patients as produced by Kiersch in his study in [1984] that he presented. So,  
I'm looking at nine years of history of the product implanted in patients, and also  
looked at their bench studies they did on wear of the product174  
171 Ibid at p. 614.  
172 Exhibit 51 T. 10 (Ryan, Doran E: Alloplastic Implants in the Temporomandibular Joint, Oral and Maxillofacial  
Surgery Clinics of North America-Vol. 1, No. 2, December 1989) at p. 428  
173 The transcript does not say 1983. It says 1993. The evidence of Doran Ryan was clear. He placed Vitek Proplast  
implants from 1983 to 1985. By 1987 he had “explanted” all of these implants. It is my assumption that the  
transcript contains a typographical error. In the transcript the Kiersch study is referred to as reported in 1994. The  
citation for that study is: “Kiersch TA. The use of Proplast-Teflon implants for meniscectomy and disc repair in the  
temporomandibular joint [Abstract]. Presented at the AAOMS Clinical Congress on Reconstruction with  
Biomaterials, San Diego, 1984”. Again, I believe the reference to 1994 is a typographical error.  
174 Transcript of Doran Ryan (June 4, 2019) at pp. 10-11  
Page: 54  
[157] In 1984 the American Association of Oral and Maxillofacial Surgeons released a report:  
“Criteria for TMJ Meniscus Surgery”. It refers to Kiersch:  
Kiersch (1984) reported 250 cases at the AAOMS Clinical Congress using  
Proplast-Teflon implants for disk repair or replacement with 93% success over a  
nine-year period.175  
[158] There were other indicators of early success. Doran Ryan provided a report in preparation  
for testifying at this trial. He referred to studies in addition to Kiersch:  
The first published results regarding Vitek ProplastR block being used as an IPI  
[Interpositional Implant] appeared in 1982. Wolford and Gallager [sic] reported  
on a series of 10 implants followed for 4 years. It was concluded that the  
ProplastR implant offered better stability because of the potential for fibrous tissue  
growth.176  
In 1986 Vitek Inc. conducted a written survey [of] Oral and Maxillofacial  
surgeons who performed TMJ joint surgery using Vitek Proplast.R The results of  
the survey showed that surgeons placed 5070 implants with a 91.5% rate of  
satisfaction.177  
Moriconi and colleagues in 1986 identified Proplast Teflon as a more predictable  
mode of temporomandibular joint reconstruction.178  
The August 1988 AAOMS position paper still recognized the use of Proplast  
Teflon IPIs in reconstruction of the TMJ.179  
[159] Doran Ryan was referred to a paper by Block, Kent and Homsy which reported a high  
degree of success with a polymer Proplast fossa prosthesis implanted in 35 severely damaged  
175 Exhibit 51 T. 3 at p. 15; Exhibit 51 T. 1 (Dr. Ryan Expert Report in the Proceeding of Kathryn Anne Taylor v.  
The Attorney General of Canada) at p. 023 citing Kiesch TA. The use of Proplast-Teflon implants for meniscectomy  
and disc repair in the temporomandibular joint [Abstract]. Presented at the AAOMS Clinical Congress on  
Reconstruction with Biomaterials, San Diego, 1984  
176 Exhibit 51 T. 1 (Dr. Ryan Expert Report in the Proceeding of Kathryn Anne Taylor v. The Attorney General of  
Canada) at p. 023 citing Gallagher DM, Wolford, LM. Comparison of Silastic and Proplast Implants in the  
Temporomandibular Joint after Condylectomy for Osteoarthritis. J. Oral Maxillofac Surg 1982;40:627-3)  
177 Ibid at p. 023  
178 Ibid at p. 023 citing Moriconi, E. Steven, Popowich, Laurence D. Guernsey, Louis H. Alloplastic Reconstruction  
of the Temporomandibular Joint; published in Dental Clinics of North America, v30 n2 p 307-325, Apr 1986  
179 Ibid at p. 023  
Page: 55  
joints in 21 patients.180 A retrieval analysis study was conducted in the early 2000’s by the  
University of Minnesota School of Dentistry. It was presented at the 68th Annual Meeting and  
Scientific Sessions of the American Association of Oral and Maxillofacial Surgeons  
(AAOMS).181 Early results are referred to:  
Certain investigators consider that the porous PTFE offered more stability than  
nonporous silicone implants. Other desirable properties that were touted were  
freedom from adverse reactions, toxillogical safety, rapid tissue in-growth, and  
biocompatibility. Early success rates for P/T [Proplast-Teflon] and Silastic  
interpositional disk implants were presented at scientific meetings and in the  
literature. One retrospective review study of 301 TMJ discectomies replaced with  
P/T by Estabrooks et al. showed an overall successful rate of 88.7% over average  
follow-up of 33 months. Bee, Gallagher, Cook, and Kiersch all reported success  
with the interpositional TMJ P/T implants. In a review of various-up studies of  
discectomy using P/T, revealed a mean satisfactory result of 91.5% supporting  
their continued use.182  
[160] This is not the only evidence suggesting that no overall consensus had been arrived at.  
Dr. John Orpin was of the view that more and better testing was required. In a letter to Dr. M.T.  
Cooper, dated January 17, 1985, he outlined a review undertaken with respect to the  
“…Characteristics and Evaluation Criteria for Safety and Efficacy of Orthopedic Implant  
Devices”:  
100 papers from the literature review, seven orthopedic surgeons were  
interviewed, 5 manufacturers were contacted. Characteristics were characterized  
into:  
(A)  
(B)  
(C)  
(D)  
Material properties,  
Biomechanical properties,  
Interaction with the Body,  
Fabrication  
Specifically fatigue strength, creep, kinematics, stress, fixation, wear,  
implantation, tissue response, degradation, corrosion, surface finish, fatigue  
strength were addressed.  
180 Transcript of Doran Ryan (June 3, 2019) at p. 70  
181 Agreed Statement of Facts at para.57 and T. 24 see also T. 23 (“Review of the 1986 Annual Scientific Sessions  
Abstracts”)  
182 Ibid at T. 24 (Improving the Management of Patients with Failed TMJ Implants: Retrieval Analysis with  
NIDCR’s TMJ Implant Registry and Repository) at p. 1 under heading "Discussion" (citations in original but  
omitted here)  
Page: 56  
The orthopedic surgeons interviewed were not uniformly agreed on assessment  
parameters; one felt that no worthwhile test could be performed. Manufacturers  
agreed that all the complex tests evaluation of strength fixation methods and  
functional characteristics should certainly be performed. Submission evaluations  
must by necessity establish a compromise in expecting performance testing of  
questionable value and should be expedited as much as possible so as not to  
discourage manufacturers from introducing new implants into Canada.  
In conclusion the report has achieved the objectives of the contract.183  
[161] A report written by Christopher K. Ober was made an exhibit to the trial.184 He is the  
Francis Norwood Bard Professor of Materials Science & Engineering and Director, Cornell  
Nanoscale Facility at Cornell University. His research includes the study of biology-materials  
interface and involves investigation of physical, surface and biological properties of many  
polymeric materials. His report is an overview presenting a general understanding of Proplast.185  
Under the last heading: State of Knowledge Regarding Biocompatibility of ProplastTM between  
1976 and 1982” Christopher K. Ober says following:  
A review of the scientific literature indicates that during the period use of  
ProplastTM implants continued throughout the 1980s and only upon FDA recall in  
1991 did these implants start to be removed.186 Even today implants of this type  
are still in use by some patients.  
[162] The fact is that throughout the 1980’s, Vitek Proplast temporomandibular joint implants  
were used and recognized by active oral maxillofacial surgeons as a viable and acceptable  
treatment.  
[163] Dr. Daniel Tomlak obtained his degree in dentistry in 1979 from what was then the  
University of Western Ontario and is now known as Western University. He interned at the  
Toronto Western Hospital during 1979-1980. In 1980 he entered the maxillofacial surgery  
program at the University of Connecticut. Daniel Tomlak regarded the program there as one of  
the best available in oral surgery. While there he was trained to do temporomandibular joint  
183 Exhibit 27 v. 3 at T. H (Letter January 17, 1985 (Dr. J.A. Orpin to Dr. M.T. Cooper)  
184 Exhibit 8(Expert Report of Dr. Christopher K. Ober, August 24, 2018)  
185 This information is provided under the headings: “Definitions of biomaterials, biofunctionality and  
biocompatibility”, “Various fluorocarbon polymer materials including ProplastTM”, “The chemistry and construction  
of ProplastTM”, “Various types of ProplastTM”, “The differences between the chemical and physical characteristics of  
the various types of ProplastTM”, “The physical properties of the films, sheets, blocks and coatings containing  
ProplastTM that demonstrate their differences”, “The absence of common elements in the chemical and physical  
properties of the various types and forms of ProplastTM” and “Provide an opinion on the state of knowledge of the  
biocompatibility of ProplastTM Polymers between 1976 and 1982”.  
186 Christopher K. Ober cites: Lee, Eisig, and Perrino. Giant Cell Reaction to Proplast\Teflon Implant. J Oral  
Maxillofac Surg 2018  
Page: 57  
implants.187 In 1980, when he entered the program, Proplast was in use in temporomandibular  
joint surgery “in some institutions”.188 Vitek Inc. came out with an interpositional material that  
was a laminate: “Teflon-Proplast”. It was approved by the FDA in 1983. It was thought to be an  
improvement. Its immediate predecessor, silastic implants (a combination of silicone and plastic)  
had a high rejection rate. It was expected that Teflon-Proplast would produce better, faster  
stabilization than silastic implants. This was part of the knowledge exchange which took place at  
roundtable discussions and seminars. The views expressed were positive about Proplast as a disc  
replacement. Daniel Tomlak was taught that Teflon-Proplast was safe and effective.189  
[164] In early 1983, after the approval of Teflon-Proplast, Daniel Tomlak went to the John  
Peter Hospital in Fort Worth, Texas. While there he worked with Dr. Larry Wolford and Dr.  
Bruce Epker. He described them as leaders in the field. They were among the top five oral  
maxillofacial surgeons in the United States. They used the Teflon-Proplast laminate implant.  
Bruce Epker and Larry Wolford agreed it was the best material for these implants. Larry Wolford  
published articles to that effect during 1983.190  
[165] What is apparent from this is that, in the early 1980’s, Vitek Proplast temporomandibular  
joint implants were accepted by the top rung of oral maxillofacial surgeons and used by them.  
[166] Later in 1983 Daniel Tomlak moved to Thunder Bay. There he worked with Dr. William  
Dowhos (who Daniel Tomlak described as the godfather of oral surgeons in Thunder Bay) and  
Dr. Eric Orpana. Daniel Tomlak spoke to William Dowhos about the regulatory status of  
Proplast. William Dowhos asked him to speak to the head operating nurse about how these  
implants could be acquired. The nurse did the research. The product was purchased from its  
Canadian supplier, Instrumentarium Inc. Its representative (Lorne Flowers) had a sterling  
reputation.191 Daniel Tomlak had no discussions about the regulatory status of Proplast. They  
were confident because of the reputation of the company and its representative. Daniel Tomlak  
testified that throughout his time in Thunder Bay he continued to educate himself. He continued  
to review journals and trade publications concerning oral surgery to stay up-to-date and  
supplement his existing knowledge. The Thunder Bay Dental Association met regularly and  
would discuss temporomandibular joint issues and surgery. He took continuing education  
courses.192 Throughout his time in Thunder Bay (1983 to 1987), as a result of his time in  
Connecticut, Fort Worth, Toronto and Thunder Bay he had no hesitation in using Proplast-  
Teflon.  
[167] In 1986 Daniel Tomlak attended a conference in Vancouver. Proplast-Teflon was not  
discussed in any of the keynote addresses, workshops or seminars. None of these formal  
187 Transcript of Dr. Daniel Tomlak (May 21, 2019) at pp. 2-4  
188 Ibid at p. 4  
189 Ibid at p.6  
190 Ibid at p. 9. (The following is a paper published in 1982: Gallagher DM, Wolford, LM. Comparison of Silastic  
and Proplast Implants in the Temporomandibular Joint after Condylectomy for Osteoarthritis. J. Oral Maxillofac  
Surg 1982;40:627-3 and already referred to at fn. 176 herein)  
191 Ibid at pp. 44 and 47  
192 Ibid at p. 15  
Page: 58  
proceedings had anything negative to say about Proplast-Teflon. As he recollected it, some  
people made favourable comments. But in “hallway conversations” with some American oral  
surgeons he was told that they had explanted more Proplast-Teflon temporomandibular joint  
implants than had been predicted. There was no mention of bone deterioration; some remodelling  
(reshaping of the bone) was both expected and referred to. There was no mention of bone  
resorption or fragmentation of the material. Nonetheless, despite the fact that this information  
was inconsistent with what he had been taught and what he had noted in his journal review with  
respect to Proplast-Teflon laminate, he stopped using it.193  
[168] From that point he monitored journals and his patients. Daniel Tomlak was hopeful that  
what he had learned was an aberration. He recognizes that this is not the case. He did not  
immediately see the problem in the literature. It did appear around 1991 although he read about it  
later, while in Kingston. He had moved there in 1987.194  
[169] In 1983 Doran Ryan began using Proplast-Teflon. Doran Ryan believes that he and his  
three partners implanted 103 patients with Proplast-Teflon IPIs over a three-year period.195  
Problems with Vitek P/TR IPI, were first noted in 1985.196 Around that time, Doran Ryan started  
observing symptoms of bone loss in patients in whom he had implanted the devices. He had an  
advantage. Because of his association with a university and its radiology department Doran Ryan  
had access to magnetic resonance imaging (MRI). Each of his patients was examined using this  
technology. With the implant failing, he took them out (“explanted” them). In March, 1989 he  
wrote a Letter to the Editor of the Journal of Oral and Maxillofacial Surgery expressing his  
concern:  
Unfortunately, Proplast/Teflon does not always withstand the forces generated  
within the joint. Gradual wear tends to lead to the development of microparticles  
which then lead to a severe foreign body reaction that destroys not only the  
condyle but also the temporal bone. The reaction is not self-limiting and can occur  
with the clinical symptoms. Many times, the loss of bone is replaced by a giant  
cell mass precluding the development of an open bite. Pain, swelling and  
limitation of opening tend to be late signs and symptoms, and by the time they  
develop the patient has severe bone loss with a defect very difficult to correct.  
[170] The letter expresses confidence that Vitek Inc. had undertaken an appropriate evaluation  
in receiving its FDA approval:  
It appears that Vitek performed the appropriate evaluation of Proplast, received  
FDA approval, and marketed a product they felt would be safe, reliable and a  
significant advancement that could treat a most complicated disease, internal  
derangement of the temporomandibular joint.  
193 Ibid at p. 19-20, 22 and 84  
194 Ibid at pp. 34-35  
195 Transcript of Doran Ryan (June 3, 2019) at pp. 59 and 76  
196 Exhibit 51 at T. 10 (Ryan, Doran E: Alloplastic Implants in the Temporomandibular Joint, Oral and Maxillofacial  
Surgery Clinics of North America-Vol. 1, No. 2, December 1989) at p. 429  
Page: 59  
[171] Doran Ryan was not critical of Vitek Inc. or its intentions:  
This letter is not to condemn the Vitek Corporation, in fact, I believe they acted in  
good faith. Instead, this letter is an attempt to help prevent serious complications  
and to bring a realistic solution to the problem. Proplast/Teflon does not always  
fail, but when it does, it can be devastating.197  
[172] In fact, he continued to take part in conferences arranged by Charles Homsy during the  
years 1984, 1985 and 1986 held to see how people were doing with his product. As late as 1987  
Doran Ryan invited Charles Homsy to take part in a conference, in Lake Tahoe, to discuss  
problems with the product.198  
[173] In his Letter to the Editor, Doran Ryan recognized that there were others who saw  
Proplast as useful and safe:  
This letter is in response to a packet of information sent to the AAOMS  
membership from the Vitek Corporation. The information packet contained letters  
from oral and maxillofacial surgeons who have used Proplast/Teflon  
interpositional implants with great success. These letters appear to defend the use  
of the implants and, in general, recommended leaving the implants unless the  
patient develops symptoms of failure. All recommended routine to follow-up. It  
appears this information was sent to counteract the negative press the product has  
recently received.199  
[174] Doran Ryan referenced three articles, one published in 1987, and another in 1990 and the  
third in 1992 each of which continued to see Proplast-Teflon implants in a positive light:  
in one of the studies 11 of 12 joints with implants showed bony changes, but there  
were only a few patients with any symptoms200;  
a second study was a multicentre evaluation conducted by Vitek, 86% of 680 P/TR  
were still in place an average of 33 months after placement, and 249 of 584 joints  
showed some degree of condylar resorption with only 24 having symptoms201;  
the third study concluded:  
197 Ibid at T. 6 (Letter to the Editor: Journal of Oral and Maxillofacial Surgery, March 1989) at p. 222  
198 Transcript of Doran Ryan (June 3, 2019) at p. 72  
199 Exhibit 51 at T. 6 (Letter to the Editor: Journal of Oral and Maxillofacial Surgery, March 1989) at p. 222  
200 Ibid at T. 1 (Dr. Ryan Expert Report in the Proceeding of Kathryn Anne Taylor v. The Attorney General of  
Canada) at p. 029 referencing: (Heffez L, Mafee MF, Rosenberg H, et al: CT evaluation of TMJ disc replacement  
with a Proplast-Teflon laminate. J Oral Maxillofac Surg 45:657, 1987)  
201Ibid at T. 1 (Dr. Ryan Expert Report in the Proceeding of Kathryn Anne Taylor v. The Attorney General of  
Canada) at p. 029 referencing: (Spagnoli D, Kent JN: Multicenter evaluation of temporomandibular joint Proplast-  
Teflon disk implant. Oral Surg Oral Med Oral Pathol 74:411, 1992)  
Page: 60  
The results of this retrospective study indicate that meniscectomies  
with Proplast-Teflon implants are a very effective form of  
treatment for TMJ disk dysfunction. Our overall surgical success  
rate of 88.7% with an average follow-up period of 33 months  
compares favorably with the surgical success enjoyed by Kiersch  
with Proplast-Teflon implants.  
Our experience has shown Proplast-Teflon to be a good  
interpositional material when a disk cannot be repaired. 202  
[175] In his report produced in preparation for appearing at this trial, Doran Ryan  
acknowledged that there was, in the early and mid-1980’s, no scientific consensus concerning  
the use of products using Proplast-Teflon:  
Despite my concerns about the Vitek P/TR IPI, there was no general scientific  
consensus on how harmful this product was, and whether all patients who had  
received the implant would suffer the symptoms of bone loss that I had  
observed.203  
[176] When it is suggested that the regulatory approval of Proplast should have been rejected  
out of hand because the risk was clear and accepted, this result conflicts with a historical context  
where significant parts of the available literature supported the use of this material, where it had  
received approval in the United States (1983), was in use by leading oral maxillofacial surgeons  
and where the regulatory scheme put in place, effective April 1, 1983 was accepted by those  
inside Health and Welfare Canada as an appropriate means of safe guarding public safety in  
terms of protecting patients from harm while providing medical devices that would be of benefit.  
[177] There is evidence from a third doctor who implanted patients. This is the evidence of Dr.  
Elliot Wayne Tunis.  
[178] Elliot Wayne Tunis did not appear. Counsel for the Ontario Health Insurance Plan asked  
that a cross-examination of Elliot Wayne Tunis be read into the record. On May 24, 2019 an  
order permitting this was made. Rule 31.11(6) of the Rules of Civil Procedure allows that where  
a person who has been examined for discovery is unable to testify because he or she has died or  
is unable to testify because of infirmity or illness or “for any other reason cannot be compelled to  
attend at trial”; a party may, with leave of the trial judge, read into the record all or part of the  
evidence given at the examination for discovery.204 A cross-examination is not an examination  
202 Ibid at T. 1 (Dr. Ryan Expert Report in the Proceeding of Kathryn Anne Taylor v. The Attorney General of  
Canada) at p. 029 referencing at fn. 37 (Lewis N. Estabrooks, DMD, Carlton E. Fairbanks, DMD, Russell J. Collett,  
DDS, and Lisa Miller, MPH, South Portland, Maine: A retrospective evaluation of 301 TMJ Proplast-Teflon  
implants, Oral Surg Oral Med Pathol September 1990) found at Exhibit 51 T. 7 at p. 384 and 385  
203 Ibid at T. 1 (Dr. Ryan Expert Report in the Proceeding of Kathryn Anne Taylor v. The Attorney General of  
Canada) at p. 028-029  
204 Rule 31.11(6) taken, in full, states:  
Page: 61  
for discovery; however, in this case, it was my understanding that Master Haberman had made  
an order, the effect of which was to incorporate the cross-examination, albeit in respect of  
another action205, into the examination for discovery in this one. (I confess that in the preparation  
of these reasons I have been unable to confirm this.) The order allowing the cross-examination to  
be read into the record was made on the acceptance of the further understanding, provided by  
counsel, that all reasonable efforts had been made to find Elliot Wayne Tunis but without  
success. Thus rule 31.11(6)(c) (“for any other reason cannot be compelled to attend at trial”) was  
applied and leave granted. In making the order, the considerations found in rule 31.11(7) were  
taken into account.206 This was a cross-examination but not in the sense that the rule raises. This  
was not a situation where the Crown, though a party to the action in which it took place, would  
have taken up the sort of examination questioning the contributions that Elliot Wayne Tunis  
might make to the action at large. However, the evidence was said to contribute to an  
understanding of how the knowledge concerning the impact of these implants evolved over time.  
This is undeniably important to this case. The question of weight and probative value remained.  
[179] From 1983 to 1987, Elliot Wayne Tunis practiced dentistry “out of the University of  
Alberta Faculty of Dentistry”. He went there as a full-time Associate Professor. From 1987 at  
least until the date he was cross-examined (February 4, 2009) he was at South Edmonton oral  
surgery”.207  
[180] While the cross-examination is not specific, it appears that, during his time in association  
with the University of Alberta, Elliot Wayne Tunis implanted a total of 44 patients with 58  
Proplast implants.208 He started using these implants on an understanding that Proplast anchored  
itself and stayed in position much better than Silastic had.209 Problems appeared. Implants failed  
much earlier than had been expected.210 A study of the 44 patients was undertaken. The  
(6) Where a person examined for discovery,  
(a) has died;  
(b) is unable to testify because of infirmity or illness;  
(c) for any other sufficient reason cannot be compelled to attend at the trial; or  
(d) refuses to take an oath or make an affirmation or to answer any proper question,  
any party may, with leave of the trial judge, read into evidence all or part of the evidence given  
on the examination for discovery as the evidence of the person examined, to the extent that it  
would be admissible if the person were testifying in court.  
205 Willekes v. University of Alberta Hospital et al. 2010 ONSC 1331 (CanLII)  
206 Rule 31.11(7) states:  
(7) In deciding whether to grant leave under subrule (6), the trial judge shall consider,  
(a) the extent to which the person was cross-examined on the examination for discovery;  
(b) the importance of the evidence in the proceeding;  
(c) the general principle that evidence should be presented orally in court; and  
(d) any other relevant factor  
207 Transcript, Cross-Examination of Elliot Wayne Tunis on his affidavit sworn August 1, 2007 at pp. 19 and 23  
208 Ibid at pp. 7, 8, 19 and 20  
209 Ibid at p. 68  
210 Ibid at pp. 19 and 23  
Page: 62  
information provided was limited. It was a small study (58 implants as opposed to several  
thousand).211 Those conducting the study did not consider that in circumstances where the  
implant was subject to “wear debris and giant cell reaction… the longer it remained implanted,  
[these reactions] would increase during the duration of the implant”.212 They thought that the  
“plastic deformation… was being caused by movement of the joint”.213 As it was understood at  
the time, it was only some patients where deformation of the implant resulted in shearing away  
of wear debris. (“We believe that happened in some of the patients and not in others”).214 Elliot  
Wayne Tunis, and those he was working with, only examined the patients who had the implants  
taken out. They had no data with respect to whether or not the wear debris that was being  
generated in the explant cases was or was not generated in the patients where the device was not  
explanted. They did not know and did not consider this possibility. It was their understanding  
that movement of the jaw did not necessarily generate wear debris.215  
[181] As a result of this work, Elliot Wayne Tunis was of the “feeling” that these implants  
carried an unacceptable risk of wear debris leading to giant cell reaction, leading to bony  
disruption.216 This was said in circumstances where they had “…patients that did real well for a  
long time”, and had “…patients that did poorly in a very short time”. They did not know what  
the difference was.217  
[182] Elliot Wayne Tunis recommended that using these interpositional implants should be  
reconsidered.218  
[183] Evidently Elliot Wayne Tunis did not feel there was great significance to the work that  
had been done. While at a conference he attended, a “poster” was prepared and “put up in a room  
and people could wander around and look at it.” Elliot Wayne Tunis did not present a paper  
formally outlining the results of the study or his recommendation. He did speak to colleagues and  
share his experience with Proplast.219 The advice he gave the Chief of his department was that  
there were “isolated failures”.220  
[184] In the circumstances, I do not give much weight to the evidence of Elliot Wayne Tunis  
provided, as it was, through the reading in of the transcript of his cross-examination. The study  
he completed was not presented in an authoritative way. What is clear is that its parameters were  
limited and its conclusions less than absolute. Some patients experienced real problems, others  
seemed to do well. Its recommendation is more suggestive than determinative. No peer reviewed  
paper or presentation of the results was published:  
211 Ibid at pp. 109-110  
212 Ibid at p.103  
213 Ibid at p. 104  
214 Ibid at p. 104  
215 Ibid at pp. 104-106  
216 Ibid at p. 111  
217 Ibid at p. 105  
218 Ibid at p. 109  
219 Ibid at p.111  
220 Ibid at p. 33  
Page: 63  
Q. But as I understood your evidence, what I thought I understood was that  
although there were degenerative changes the thinking was not that it was, at the  
time, due to the implant?  
A. In 1985 we didn’t know the cause of the degenerative changes. We didn’t  
know why they were happening, whether it was an implant or something else. We  
were just trying to look and see what was happening and then eventually patterns  
started to arise, but not for a while.  
Q. And did you know any more in February ‘86 or July ‘86 when you presented at  
that conference?  
A. Well, I think once we had this information we had a pattern established that I  
was concerned about. And it didn’t imply that every implant would fail, but that a  
certain number had failed in a certain time period. And this was a concern to  
me.221  
[185] In the midst of this uncertainty, the lack of any true cross-examination by an adverse  
party detracts from the weight and value of this evidence.  
[186] There was evidence presented that it was years later before there was a more certain or  
complete understanding of the harm that is associated with temporomandibular joint implants  
that made use of Proplast. Dr. Heather Sheardown is associated with several universities in  
Ontario. She is a Professor in the Department of Chemical Engineering at McMaster University,  
an Adjunct Professor in the same department at the University of Ottawa and an Adjunct  
Professor at the School of Optometry. Although her work has concentrated on the eye with  
limited application to weight bearing joints, she has special expertise in biomaterials engineering  
and analysis including the response of the body to biomaterials. She has written numerous peer-  
reviewed publications on natural and synthetic biomaterials. The majority of her academic work  
is concerned specifically with the development, design and testing of new biomaterials, in many  
cases for long-term implantation, in the human body.222  
[187] As part of the evidence she presented at trial, Heather Sheardown provided and reviewed  
articles which examined the impact of Proplast implants years after the early and mid-1980s.  
Heather Sheardown referred the Court to a paper published in 1996. The title was: “Morphologic  
and Immune Histochemical Observation of Explanted Proplast-Teflon Temporomandibular Joint  
Interpositional Implants”. The study was limited to a specific Proplast implant:  
The Proplast-Teflon (Vitek, Inc., Houston, TX) interpositional implant (PTIPI),  
introduced in 1973, gained widespread use during the early and mid-1980s. The  
implant consists of Teflon fluorinated ethylene propylene (E.I. DuPont Co.,  
221 Ibid at p. 152  
222 Exhibit 50 T. 1 (Curriculum Vitae of Heather Scheardown) and T. 2 (Report of Dr. Heather Sheardown, August  
20, 2018)  
Page: 64  
Wilmington, DE) laminated to Proplast II (Teflon polytetrafluoroethylene and  
aluminum oxide).  
[188] The paper reviews the placement and expectations for the implant:  
The Proplast surface is placed toward the glenoid fossa to allow ingrowth of bone  
and fibrous tissue into its porous structure to increase implant stability; the  
smooth Teflon surface faces the articulating area of the condyle.  
[189] The Abstract that introduces the paper states its purpose:  
Purpose: The objective of this study was to investigate the cellular tissue response  
to temporomandibular joint (TMJ) Proplast-Teflon disc material by morphologic  
and immunohistochemical means.  
[190] The Abstract cites the conclusion reached:  
Conclusions: The study of the PTIPI-induced tissue reaction gave no indication of  
a toxic or an immunologic pathogenesis. Mechanical stress seems important in the  
fragmentation of the implant and induction of the foreign body reaction. It is not  
yet known if this fragmentation is the major contributing factor.223  
[191] Heather Sheardown also referenced a paper from 2008: “Evaluation of Surgically  
Retrieved Temporomandibular Joint Alloplastic Implants-Pilot Study”. It identified the product  
(Proplast), the problem (fragmentation) and the regulatory response that had been implemented  
but made clear there was still not a complete understanding of the mechanisms in play:  
In the late 1980s, Proplast/Teflon TMJIP were found to brake [sic] or be rejected  
in many patients, because of the high biomechanical force placed on them [a series of  
footnotes are referred to] The break down led to production of fragmented particles which  
[more footnotes]  
resulted in an immune foreign body response  
causing problems  
ranging from severe cutaneous inflammatory reaction in the pre-auricular and  
cheek areas [another footnote]; to severe degenerative joint disease with resorption and  
erosion of the TMJ bony structures, perforation into the middle cranial fossa [three  
more  
footnotes], chronic pain, increased joint noises, TMJ hypermobility, and  
malocclusion. The result was a dramatic clinical spectrum of failures for these  
[More footnotes referred to]  
implants.  
The December 1991 issue of the US Foods and  
Drugs Administration Bulletin recommended immediate removal of all previous  
TMJ Proplast/TeflonR IPs, June 2 mechanical failures, resulting in progressive  
[two additional footnotes]  
bone degeneration.  
The American Academy of Oral and  
223 Exhibit 50 at T. 8 (Ida Gjessing Trumpy, MD, DDS, MHA, Borghild Roald, MD, Phd, and Torstein Lyberg, MD,  
DDS, Phd; Morphologic and Immune Histochemical Observation of Explanted Proplast-Teflon Temporomandibular  
Joint Interpositional Implants, J. Oral Mavillofac Surg 54:63-68, 1996) at p.63  
Page: 65  
Maxillofacial Surgery (AAOMS), in a 1992 workshop, mandated the  
discontinuation of Proplast/TeflonR IPs.224  
[192] The paper demonstrates that, even in 2008, those involved were learning about the shape,  
size and danger of the particles that resulted from fragmentation of the implant. There were three  
paragraphs making up the “SUMMARY AND CONCLUSIONS” of the paper. The first notes:  
This pilot study demonstrated that pain was a significant correlate to perforation  
of the alloplastic TMJ IP implants. This finding has been speculated elsewhere [two  
footnotes]  
but it is scientifically demonstrated here for the first time. Patients with  
these TMJ implants devices report difficulties in tolerating their pain symptoms.  
Moreover, Teflon materials present in these implants appear to structurally fail  
and cause a FBGCR [Foreign Body Giant Cell Reaction] in the TMJ. The cause  
of this breakdown may be multifactorial.  
[Emphasis added]  
[193] This conclusion demonstrates that those interested in the area were still learning and that  
there was more to learn. The second of the three paragraphs suggests better techniques were  
being developed to assist in this work:  
Stereo zoom microscopy may constitute a good quality technique to investigate  
biomechanical failure patterns on the surface of implant devices. Electron  
Microprobe analysis (with line profile and element mapping) can be an  
appropriate procedure to evaluate the surface of implant devices, analyze the  
quality and quantity of different chemical phases present.  
[194] The third paragraph observes:  
Of this pilot research also provided new information on the problems associated  
with past implant materials, and these findings may assist in developing other  
appropriate types of TMJ implants materials more resistant to perforation and  
breakage. These new TMJ materials should be biocompatible and able to resist to  
TMJ biomechanical forces, without producing wear debris.225  
[195] The search for materials that would perform without fragmentation (wear debris)  
continued.  
[196] This continuing search for answers and the evolutionary nature of the understanding and  
knowledge, as reflected in this paper, was recognized by Doran Ryan:  
224 Ibid at T. 9 (Joao N.A.R. Ferreira, DDS MS, Ching-Chang KO, DDS MS Phd, Sandra Myers, DMD, James  
Swift, DDS, James R. Fricon, DDS; Evaluation of Surgically Retrieved Temporomandibular Joint Alloplastic  
Implants-Pilot Study J Oral Maxillofac Surg. 2008 June; 66(6):1112-1124) at p. 2  
225 Ibid at T. 9 (Joao N.A.R. Ferreira, DDS MS, Ching-Chang KO, DDS MS Phd, Sandra Myers, DMD, James  
Swift, DDS, James R. Fricon, DDS; Evaluation of Surgically Retrieved Temporomandibular Joint Alloplastic  
Implants-Pilot Study J Oral Maxillofac Surg. 2008 June; 66(6):1112-1124) at p. 8  
Page: 66  
THE COURT: Sorry, I just want to clarify something. Just a minute. You said that  
in what I understand to be a fairly absolute way, and I just want to confirm my  
memory from yesterday, that yesterday the proposition was that the body was… I  
thought the proposition was that there are some kinds of particles that the body is  
capable of absorbing and dealing with either, I think you said, it can flush them  
out through the flow of bodily fluids is one option. The other option was that the  
body naturally encapsulates the particle and, in effect, separates it from the rest of  
the body and, therefore removes any harm. There are some particles that that can  
happen with. There are some particles that that cannot happen with, and I believe  
you said that the particular problem or a particular problem associated with the  
particles that broke away from the Proplast was that they had jagged edges and,  
therefore, any effort by the body to encapsulate them would fail because it breaks  
up the encapsulation and, therefore, leaves the body exposed to the particle. Have  
I got that right?  
A. Your Honour, yes, that’s correct.  
THE COURT: What I take from that, therefore, is that what happened here is that  
the body’s protection—  
I don’t want to say, protection. Efforts, I’m not sure that’s the right word.  
Protection tools…  
MR. NEWLAND: Self-defence.  
THE COURT: Self-defence. Didn’t function with respect to these particular  
particles?  
A. Yes  
THE COURT: Just to be clear about this in the context I’m putting this into, we  
did hear some evidence from another witness that there was a paper written as late  
as 2008 which in some fashion—I don’t think I’ve read the paper but she talked  
about it. Some fashion, examined that question and noted, for example, that the  
particles were, I think jagged edged, and I think quite large. I think that was the  
other proposition.  
A. Yes it was.  
THE COURT: My point being, it would appear from that, at least from my  
perspective that the literature surrounding this question was developing over time  
to the point where it was still being looked at as late as 2008. Do you know that?  
A. yes  
Page: 67  
THE COURT: Okay, thanks.226  
[197] I return to an observation made earlier in these reasons. Science does not tend to develop  
its understanding in moments of insight or clairvoyance. These understandings develop over  
time. It is the position of the Plaintiff that as a result of the work of Daniel Tomlak, Doran Ryan  
and Elliot Wayne Tunis the dangers of Proplast should have been clear to the point where there  
should have been no granting of any Notice of Compliance. Daniel Tomlak’s decision to stop  
arose not from any paper or study referred to at the conference he attended. It was a hallway  
conversation; not one where bone deterioration was raised. The concern was that more of these  
implants had been taken out than had been predicted. I have already indicated that I do not give  
much weight to the evidence of Elliot Wayne Tunis. The study he undertook was small and  
limited. Its conclusions were not determinative and no peer reviewed paper or presentation was  
published or brought forward. Doran Ryan stopped implanting Proplast products but continued  
to inquire. The letter he wrote in March, 1989 to the Editor of the Journal of Oral and  
Maxillofacial Surgery demonstrates his view at that time. Unhappily and for whatever reason the  
quotations relied on by the Submissions of the Plaintiff only quote those parts that indicate the  
concern, not those that explain Doran Ryan’s overall view. These quotations do not indicate:  
the acknowledgement that Vitek Inc. had acted in good faith,  
the purpose of the letter as an “attempt to help prevent serious complications and  
to bring a realistic solution to the problem”,  
the understanding that Vitek Inc. had performed the appropriate evaluation of  
Proplast,  
that there were letters that appeared to defend the use of the implants,  
in general, recommended leaving the implants unless the patient develops  
symptoms of failure, and  
that articles continues to be published that saw Proplast in a positive light.  
[198] The importance of the article of 2008 referred to by Heather Sheardown (“Evaluation of  
Surgically Retrieved Temporomandibular Joint Alloplastic Implants-Pilot Study”) is not, as the  
Submissions of the Plaintiff would have it, to advocate that the regulator required “…scientific  
consensus or worse still certainty before conducting a recall”.227 Rather it is to show that the  
scientific understanding remained incomplete. That the work continued, even 18 years after the  
recall of all Proplast products. I repeat science tends to evolve and, generally, is not subject to  
moments of comprehensive understanding.  
[199] I have not as yet said anything concerning the substance of the evidence provided by  
Robert Pilliar. He testified that the “steps” that complete the understanding of the problems with  
226 Transcript of Doran Ryan (June 4, 2019) at pp. 27-29  
227 Submissions of the Plaintiff at para. 74  
Page: 68  
Proplast were identified and understood as long ago as 1963. That is years before the formation  
of the Medical Devices Bureau. The foundation for this understanding is what counsel for the  
Plaintiff described as a “paper” written by Dr. John Charnley in that year. It was not a paper. It  
was a “letter to the editor” published in The Lancet on December 28, 1963.228 It was not peer  
reviewed. It is said to be a “warning against the use of P.T.F.E. where abrasion with the  
liberation of particles is likely”.229 There is no demonstration of the evidence upon which this  
“warning” is founded but there is a statement that “the paper on this subject” will likely not be in  
print for another two years. The promised paper was published in 1969.230  
[200] Robert Pilliar acknowledged that John Charnley’s letter to the editor included statements  
that contained a measure of speculation. Considered alone one could not extrapolate any  
conclusions about the temporomandibular joint.231 The 1969 paper reported on an analysis of  
PTFE [Teflon] wear debris from different sized implants used in hips. Robert Pilliar agreed that  
the temporomandibular joint and hip joints have a “completely different geometry”, which meant  
that the conclusions reached with respect to the use of Teflon hips were not directly transferable  
to the temporomandibular joint.232 As it is the replacement hip joints functioned very well.233  
Robert Pilliar also acknowledged that John Charnley appeared to conclude that the release of  
small amounts of PTFE was not intrinsically harmful to patients.234 Robert Pilliar agreed that  
these questions raised concerns about the conclusions suggested as having been raised in the  
paper attributed to John Charnley:  
THE COURT: I want to now just go back and pretend we’re reading this in 1968  
and propose to you that relying on this work in a as if we had a finished  
conclusion about the validity of these TMJ joints would have been, to put it  
kindly, speculative, but this just doesn’t support, it seems to me at the moment,  
that kind of conclusion.  
228 Exhibit 10  
229 Exhibit 10 at p. 1379 and Transcript of Robert Piliar (April 10, 2019) at p. 52  
230 Exhibit 11  
231 Transcript of Robert Pilliar (April 10, 2019) at p. 44  
232 Ibid at p. 84 and 86  
233 Exhibit 11 (John Charney 1969 paper) at p. 35: Under the heading “The biological cause of failure” there is the  
observation that while there appeared to be some problems:  
these artificial hips functioned very well even with the plastic socket grossly worn  
234 Transcript of Robert Pilliar (April 10, 2019) at p. 82 and see Exhibit 11 (John Charney 1969 paper) at p. 35:  
It would appear that P.T.F.E. proved unsuitable for this type of surgery because it produced  
particulate matter too fast for the tissues to dispose of it. In small amounts there seems nothing  
intrinsically harmful in particles of P.T.F.E. since we have many instances of this material in  
human tissues where it becomes sealed off and later becomes calcified, over a period of seven  
and eight years.  
Page: 69  
THE WITNESS: I agree.235  
[201] A review of the paper demonstrates that it would have been wrong and speculative to rely  
on it as a confirmation that these kinds of prosthesis should not be used and were dangerous.  
[202] This being so it is apparent that no definitive conclusion as to the impact and effect of  
Proplast temporomandibular joints was available in 1963 or 1969. The idea that somehow more  
was known than this evidence suggests would be contrary to the collective evidence of all of  
Doran Ryan, Daniel Tomlak, Elliot Wayne Tunis, Heather Sheardown and a proper appreciation  
of what was said by both Pierre Blais and Robert Pilliar. An example of what was left to be  
learned is the question of whether and to what extent the temporomandibular joint is weight  
bearing. Whether it is weight bearing and how the load is distributed impacts the tendency of  
particles to break away. Robert Pilliar acknowledged that even in the 1980’s there were oral  
surgeons who did not believe that the temporomandibular joint was weight bearing.236 Even  
today while the presence of loading is generally accepted there remains some question as to the  
actual impact. Doran Ryan testified that compressive load is not directly into the joint itself but  
on the articular eminence, and that to this day no one really knows how much load is placed on  
the temporomandibular joint.237 Elliot Wayne Tunis, in the cross-examination admitted as  
evidence, testified that as of 1986 oral surgeons did not consider temporomandibular joints to be  
weight bearing.238  
[203] Robert Pilliar’s core conclusion, as relied on by the Plaintiff, is found in an affidavit he  
swore on October 11, 2000:  
A reasonable and professionally trained scientific reviewer in 1975 should have  
questioned the use of these materials (silastic [silicone], proplast, Teflon or  
acrylic) as bearing services for joint replacement applications, including TMJ, and  
would have requested appropriate testing to improve the efficiency and durability  
of these materials for such applications.  
[204] It may well be that in 1975 there was more to be learned about the processes both  
mechanical (the working of these devices) and human (understanding the body’s response). The  
tracing of the history suggests that this is exactly what happened. The Court was presented with a  
paper by Mark G. Fontenot and John N. Kent which, in its opening paragraphs, provides a short  
view of the evolution of what had been learned. Fontenot and Kent realized that there was little  
reporting on the problems with Proplast TMJ Disc Implants and, therefore, undertook their study  
which was reported in 1992.239 The paper begins with the historical overview:  
235 Ibid at pp. 82-87  
236 Ibid at pp. 10, 42-43  
237 Transcript of Doran Ryan (June 3 2019) at pp. 53-54  
238 Transcript, Cross-Examination of Elliot Wayne Tunis on his affidavit sworn August 1, 2007 at p. 104  
239 Exhibit 9 (Fontenot: Mark G., Kent, John N.: In Vitro Wear Performance of Proplast TMJ Disc Implants, J.  
Oral Maxillofac Surg 50: 133-139, 1992) at p. 133  
Page: 70  
1. 1970 Interpositional Implants using Teflon were in place. There was early and short-term  
success;240  
2. by 1983 hundreds of implants were put in place; by 1986 it was thousands;241  
3. in 1986 reports began describing biomechanical failures… that caused adverse tissue  
reaction and bone resorption;242 and  
4. in 1986, at an annual meeting of the American Association of Oral and Maxillofacial  
Surgeons the presence of debris was identified. “Several clinicians reported  
biomechanical failure of both Proplast I and II laminated to Teflon FEP used as disc  
replacement in patients and animals.”243  
240 See footnote 3 to the Fontenot paper. This success was reported in Kiersch TA. The use of Proplast-Teflon  
implants for meniscectomy and disc repair in the temporomandibular joint [Abstract]. Presented at the AAOMS  
Clinical Congress on Reconstruction with Biomaterials, San Diego, 1984”. The Fontenot and Kent paper begins  
(and leads to the footnote) with:  
In the early 1970s, Teflon FEP (fluorinated ethylene propylene; E. I. Dupont De Nemours & Co,  
Wilmington, D.E.) film was laminated to porous Proplast I (Teflon polytetrafluoroethylene  
[PTFE] and carbon; Vitek Inc., Houston, TX) and short-term success was subsequently reported  
using this sheeting as a temporomandibular joint (TMJ) condylar cap without disc removal.  
Based on these early successes….  
[Emphasis added]  
The Fontenot and Kent paper goes on to refer to the paper by Kiersch:  
This Proplast-Teflon interpositional implant (PTIPI; Vitek, Inc., Houston, TX) was used as a  
TMJ disc replacement and Kiersch was the first to report on its successful use.  
241 Exhibit 9 (Fontenot: Mark G., Kent, John N.: “In Vitro Wear Performance of Proplast TMJ Disc Implants”, J.  
Oral Maxillofac Surg 50: 133-139, 1992) at p. 133:  
In the United States, the use of interpositional TMJ implants for disc replacement, primarily  
silicone rubber (Silastic; Dow Corning, Midland, MI) and PTIPI, escalated from hundreds  
annually in 1983 to thousands by 1986.  
242 Ibid at p. 133:  
However, reports begin describing biomechanical failure of the PTIPI that caused adverse tissue  
reaction and bone resorption in both animals and humans.  
243 Ibid at p. 133:  
At the 1986 annual meeting of the American Association of Oral and Maxillofacial Surgeons  
(AAOMS), several clinicians reported biomechanical failure of both Proplast I and II laminated  
to Teflon FEP used as disc replacement in patients and animals.  
Page: 71  
[205] It may be that through the lens of hindsight all seems clear, at least to some people. It was  
not so at the time. The evidence demonstrates continued learning through the 1980’s and beyond.  
The paper written by Mark G. Fontenot and John N. Kent was published in 1992 but, even then,  
does not definitively pronounce the end of the utility of Proplast TMJ disc implants. The abstract  
for the paper was as follows:  
This study investigates the in vitro performance of Proplast-Teflon Interpositional  
Implants (PTIPI: Vitek, Inc., Houston, TX), employing a mechanical TMJ  
simulator. Predictions of in vivo service life of PTIPIs are presented based on the  
in vitro wear testing data. Commonly employed laboratory testing methodologies  
are discussed in the development of alloplastic TMJ devices. Penetrative wear  
rates of the PTIPI at a 20-lb (9.1 kg) load were calculated to be 2.29 mm/100,000  
cycles, yielding a predicted in vivo service life of PTIBIs of approximately 3  
years. These results combined with reported clinical fate of this implant indicate  
that the intermediate-and long-term survival of this implant are uncertain.  
[Emphasis added]  
[206] Even so, I do not wish to be taken as saying it is only when knowledge is comprehensive  
and complete that the concern can be of a degree calling for a regulatory response. That can  
come earlier. The American Academy of Oral and Maxillofacial Surgery (AAOMS) convened a  
conference in November 1992 - of which Doran Ryan was one of the organizers - to determine  
what parameters of care should apply to patients who had received temporomandibular joint  
implants. The conference consisted of a comprehensive review of the relevant literature.244 At  
the conference, the AAOMS developed a consensus position that the use of Proplast-Teflon IPI’s  
should be discontinued because it was an inappropriate material for this purpose. However, even  
at this stage there was a lack of consensus in terms of whether Proplast-Teflon IPI’s needed to be  
removed in asymptomatic patients.245 A minority believed that this was not necessary. During  
October 1993, the AAOMS’s published “Recommendations for Management of Patients with  
Temporomandibular Joint Implants” in the Journal of Oral and Maxillofacial Surgery based on  
the consensus positions raised at the November 1992 conference. It was only at this time that a  
consensus was reached in the oral and maxillofacial surgical community about the risks  
associated with the use of Proplast-Teflon IPI.246  
THE APPLICATIONS FOR NOTICES OF COMPLIANCE  
[207] The evolution of the understanding of the harm as opposed to the benefit of the  
Proplast247 temporomandibular joint implants being as I have described, there could be no clear  
or preordained outcome to any submissions made seeking the issuance of Notices of Compliance  
for these products. To my mind, this is where the central issue in this case arises. How were  
244 Agreed Statement of Facts at para. 76; Transcript of Doran Ryan (June 3, 2019) at pp. 92-93; Exhibit 51 T. 12  
245 Transcript of Doran Ryan (June 3, 2019) at pp. 92-100; Exhibit 51 T. 12 at p. 1166  
246 Agreed Statement of Facts at para. 78; Transcript of Doran Ryan (June 3, 2019) at pp. 98-99; Exhibits 51 T. 12  
and 8 at p. 46  
247 Submissions of the Plaintiff at para. 27  
Page: 72  
these applications dealt with? Were they analyzed as the Medical Devices Regulations required?  
Is there a demonstrated duty of care owed to any members of the class in the conduct of the  
evaluation and determination as to whether any Notice of Compliance should be issued? As it is,  
these applications were, for the most part, rejected. On this basis there is little room or reason for  
the Plaintiff to complain about the considerations brought to bear by the representatives of the  
Crown.  
[208] The first of two series of applications was made, that is, material was received by Health  
and Welfare Canada, on or about March 17, 1987.248 The substance of the test and the process  
was set by the amendment to the Medical Devices Regulations which became effective April 1,  
1983. Prior to that date all that would have been required was a notification to Health and  
Welfare Canada of the intention to import and market the product in Canada. In such a situation  
it would have been open to the Crown to request the studies that had been done to support the  
marketing of the product. In this case, the Plaintiff asserted, and the Crown acknowledged, that  
no such notification had been provided. In the period following April 1, 1983 there were two  
mechanisms available through which a medical device included on the schedule associated with  
Part V of the Medical Devices Regulation could be permitted for sale in Canada. The first would  
apply if it could be shown that the product had been sold here prior to the effective date of the  
revised regulations. This is what was referred to as “grandfathering”. The Crown readily  
acknowledged that it could not rely on this as a means by which the Vitek Proplast products were  
or could have been sold in Canada. The Vitek Proplast implants required a Notice of  
Compliance, the second of the two mechanisms.  
[209] On January 12, 1983, in preparation for the coming into effect of the amended Medical  
Devices Regulations, the Health Protection Branch of what, at the time, was still known as  
Health and Welfare Canada, issued an Information Letter.249 It was distributed to “Manufacturers  
and distributors of Medical Devices” and to “Hospital Administrators”. It was further to an  
earlier Information Letter that had been issued on June 21, 1982 which had proposed the  
amendments “to modify the table to Part V to include the devices designated for implantation  
into the tissues or body cavities of a person for thirty days or more.”250 This further Information  
Letter outlined the expectations for submissions that were to be made:  
The requirements of Part V apply only to ‘new devices’ as defined in the  
regulations. For these, the manufacturer must submit the required information in a  
reasonable format for evaluation. Publication 82-EHD-55 “Guideline to Part V of  
the Medical Devices Regulations”, designed to aid in the preparation of a  
submission, is available upon request. …  
[210] And the impact and meaning represented by the granting of a Notice of Compliance:  
A notice of Compliance [sic] issued by the Branch after evaluation of the  
submission does not signify approval. It does, however, provide users with the  
248 Exhibit 12 T. 4 (Submission Control Form)  
249 Exhibit 19 (Information Letter No. 638)  
250 Ibid (Information Letter No. 638 referring to Information Letter No. 625)  
Page: 73  
assurance that the Branch is satisfied that the manufacturer has carried out tests  
and has submitted appropriate results to demonstrate a reasonable probability of  
the safety and effectiveness in humans. The onus of ensuring safety and  
effectiveness of the device remains with the manufacturer.  
[211] And concludes with the following:  
Since all new devices will not be labelled to indicate that the products have  
received Notices of Compliance, purchasers of these devices may obtain  
information about the status of the device by writing to…[Address provided] 251  
[212] What this Information Letter did was to confirm the fundamental responsibilities of each  
of the parties to the collaborative process referred to by Janice Hopkins: the provider of the  
product (the manufacturers and distributors) was required to do the studies and demonstrate the  
safety and efficacy of the new device; the government (the regulator) confirmed that tests had  
been done and appropriate results demonstrated and users (the hospitals) were left to confirm for  
themselves that a Notice of Compliance had, in fact, been issued. The significance of the  
recognition that the granting of a Notice of Compliance was not an approval is that this process  
did not provide an assurance that the product was safe and effective; only that there was a  
reasonable probability that it was. Any decision as to its use for any particular purpose was left to  
the user, the medical professional.  
[213] It should not be forgotten that there are competing values that need to be balanced. The  
desire to provide products of benefit to those that are ill, challenged, impaired or in pain but to do  
so within an acceptable degree of risk.  
[214] Quite apart from the general efforts made to advise those interested of the new  
requirements and procedures there was some specific communication and advice given to Vitek  
Inc. On May 10, 1983 (that is to say, one month after the implementation date of the amendment  
to Part V of the Medical Devices Regulations) the Medical Devices Bureau received a letter from  
Vitek Inc. advising that the company was planning to export three unapproved non-  
temporomandibular joint Proplast devices to Canada. Vitek requested a letter from Health and  
Welfare Canada stating that the import of these devices into Canada was permitted and was not  
contrary to Canadian law.252 By letter dated May 17, 1983, Health and Welfare Canada  
responded. The devices in question were subject to Part V of the recently amended Medical  
Devices Regulations. Vitek Inc. was advised that Notices of Compliance were required before  
these devices could lawfully be sold in Canada and, accordingly, that evidence regarding the  
safety and efficacy of the devices was to be provided. The letter enclosed a copy of the Part V  
Submission Guidelines and a copy of the Medical Devices Regulations.253 On May 25, 1983,  
Storz Instrument Company, an American distributor of Proplast implants, wrote to the Medical  
Devices Bureau. The letter was an attempt to provide notification of the Proplast-based devices,  
251 Ibid (Information Letter No. 638)  
252 Agreed Statement of Facts at paras. 81-82 and T. 50; Exhibit 14 at p. 57  
253 Ibid at paras. 83 and T. 51; Exhibit 14 at p. 56  
Page: 74  
presumably to avoid the requirements of Part V.254 In a further letter, this one dated October 31,  
1983 Health and Welfare Canada reiterated that these products could not be sold, in Canada,  
without a Notice of Compliance.255 A further copy of the Part V Submission Guidelines and the  
Medical Devices Regulations were enclosed. It was not until the submission received by Health  
and Welfare Canada on March 17, 1987, that any application seeking Notices of Compliance for  
Proplast products was made by Vitek Inc. or anyone else on its behalf.  
[215] Nirmala Chopra began her career in England. In 1970, she joined Health and Welfare  
Canada. In 1976, shortly after its formation, she moved to the Bureau of Medical Devices and, in  
1979, was put in charge of pre-market review. She was there through 1983, when the amended  
regulation was put in place. As a technical matter she remained in that position until 1990 when  
she left due to a disability. In fact, during 1988 she was seconded to a department dealing with  
the AIDS epidemic and did not return.  
[216] Almost from the outset there were concerns with respect to the ability of the Bureau of  
Medical Devices to review and respond to the demand that followed the implementation of the  
amendments to the Medical Devices Regulations. On November 13, 1985, there was a meeting  
of the “Dental Task Force”. The Minutes reveal that those present, which included Nirmala  
Chopra, considered an article she had written that was being proposed for publication in the  
Canadian Dental Association Journal. Among other things, the article referred to the volume of  
available devices:  
Advances in various fields of Science and Engineering in recent decades have  
resulted in the availability of a wide variety of medical devices for therapeutic and  
diagnostic purposes. There are roughly 320,000 devices comprising  
approximately 100,000 trade names. These devices are manufactured by 2500  
manufacturers of which approximately 20% are Canadian.  
Most devices used in Canada are imported from 35 countries with the majority of  
these being from the United States. Controls in these countries vary from virtually  
no regulations or controls to others [that vary] greatly in extent.  
[217] The benefits and competing risks were made apparent:  
Although there is no doubt that devices have improved the health and well being  
of the public and reduced morbidity and mortality, there are also reports atributing  
[sic] morbidity and mortality to hazardous and ineffective devices.  
[218] The paper goes to observe that different classes of devices may, in turn, be treated  
differently:  
In addition to these general regulations, certain classes of devices are subject to  
greater regulatory controls. These controls fall into two categories - premarket  
254 Exhibit 16 at p. 119  
255 Agreed Statement of Facts at para. 84 and T. 52; Exhibit 16 at p. 114  
Page: 75  
review and the establishment of standards. The criteria for requiring some device  
classes to meet standards may be quite different to criteria for requiring premarket  
review. 256  
[219] Apprehensions surrounding the regulation of certain devices were raised. The responses  
were in line with the understanding of distinctive treatment. Concerns had been expressed  
regarding “dental implants” and the fact that they all required the issuance of Notices of  
Compliance under Part V of the Medical Devices Regulations as it had been amended:  
All dental implants and restorative materials came under definition of “Implants”  
and were subject to premarket review. However, representations were received  
from the dental industry seeking clarification of the status of certain restorative  
materials.  
[220] In response to those representations, on October 9, 1985, the Health Protection Branch  
published Information Letter No. 696 to “Manufacturers Distributors of Dental Devices”:  
Dental Implants  
The Medical Devices Regulations were amended, effective April 1, 1983, to  
require premarket review of all devices designed to be implanted into the tissue or  
body cavities of a person for 30 days or more.  
Representations have been received from the dental industry seeking clarification  
of the status of certain dental restorative materials insofar as premarket review is  
concerned. As a result of discussions with representatives of the Canadian Dental  
Association, the Dental Industry Association of Canada, and the Canadian  
Association of Manufacturers of Medical Devices, it has been decided that dental  
materials defined as those devices attached only to non-vasculararized tissue or  
the oral cavity having no direct access to systemic or lymphatic circulatory  
systems will not be treated as implants.257  
[221] This was not the only expressed concern. An earlier Information Letter, this one No. 675,  
had been issued on February 8, 1985 and considered the impact of the amendments on products  
that otherwise might have been considered as “Grandfathered”. It, too, was distributed to  
“Manufacturers and Distributors of Medical Devices”:  
1. Modified Implantable Devices  
Concerns expressed about the delay in obtaining certain implantable devices  
which have recently been modified and therefore become subject to Part V of the  
Medical Devices Regulations. Implantable devices which were being sold prior to  
April 1, 1983, do not need a Notice of Compliance, however, if the device is  
256 Exhibit 27 v. 3 at T. P  
257 Exhibit 30 at p. 7  
Page: 76  
modified, it becomes a “new device” as defined in Part V of the regulations. The  
manufacturers must then submit test data and performance information for  
evaluation; if the information is determined to be acceptable, a Notice of  
Compliance will be issued to allow general sale.  
Starting immediately a Notice of Compliance will be issued to allow the sale of a  
modified device for a limited period if submitted information about the  
modification is considered adequate to show that no adverse effects will result.  
However, the manufacturer will be required, pursuant to Section 41 of the  
Medical Devices Regulations, to make a full submission for the device as  
indicated under Section 35 within one year from the date of such Notice of  
Compliance. In the event that the submitted information is not satisfactory, the  
Notice of Compliance may be cancelled under the authority of Section 40.258  
[222] These modifications made with respect to the treatment of “grandfathered” devices and  
the clarification of what would be understood to be a “dental implant” for the purposes of Part V  
of the Medical Devices Regulations are both in furtherance of balancing the competing values of  
bringing to market medical devices which would assist patients but doing so without a  
disproportionate risk of harm. Even if this were not so, these changes would have no impact on  
this case. Again, it was acknowledged by the Crown that the Vitek Proplast implants were not  
subject to grandfathering and were to be treated as “new devices”. Temporomandibular joint  
implants are attached to the vascular system and, accordingly, are implants requiring compliance  
with Part V of the Medical Devices Regulations. They are orthopaedic and not dental implants.  
[223] In 1984 the Environmental Health Directorate, at the time the responsible section of the  
Health Protection Branch, published a “Guide to the Preparation of a Submission Pursuant to  
Part V of the Medical Devices Regulations”. It sets the stage for such a submission:  
It must be noted that there is no authority or mechanism under the Food and  
Drugs Act to approve a medical device prior to its sale in Canada. It is the  
responsibility of the manufacturer to ensure that the regulatory requirements are  
met. Thus, for all devices except those listed in the Table to Part V, provided the  
manufacturer can demonstrate on request that a device is safe, effective and  
adequately labelled, he need only submit notification information as described in  
Part II. For devices subject to Part V there are additional requirements. Certain  
information and material must be submitted before sale to substantiate that the  
new device has been adequately tested to demonstrate safety and high probability  
of effectiveness in humans. If such information is adequate the Director (for this  
purpose the Assistant Deputy Minister, Health Protection Branch) issues a Notice  
of Compliance. If the evidence is unsatisfactory or inadequate, a Notice of  
Compliance may be denied pending additional information requested. Sale of a  
258 Exhibit 34 v. II at T. 93  
Page: 77  
new device without receipt of a Notice of Compliance is a violation of the  
Medical Devices Regulations.259  
[224] Following its receipt, the March 17, 1987 submission seeking Notices of Compliance for  
the Vitek Proplast products was passed to Nancy Shadeed for review. Although done under the  
general direction of Nirmala Chopra within the auspices of what, at the time, was called the  
Bureau of Radiation and Medical Devices, Nancy Shadeed was employed elsewhere in Health  
and Welfare Canada. She was part of the Clinical Criteria section. During the latter half of 1986  
and 1987 she worked doing premarket review. There was not enough work at the Clinical  
Criteria Section. There was a backlog at premarket review.260 Her role was to prescreen the  
submissions to be sure they were complete.261 If accepted as complete, an application was then  
reviewed as to sufficiency and adequacy. As was explained later by Dr. Richard Lawuyi, the  
reviewers met once a week (“submission meeting”). The reviewer responsible for any particular  
submission would present to the others and make a recommendation. There would be some  
discussion and, Nirmala Chopra, as the responsible supervisor, would agree or not with the  
recommendation that had been made.  
[225] In this case, the submission received on March 17, 1987 was acknowledged by a letter  
dated May 16, 1987 and signed by Nirmala Chopra as Head, Premarket Review, Division of  
Clinical Assessment, Bureau of Radiation and Medical Devices. What was made plain by this  
letter is the large number of applications included as part of this submission:  
Thank you for your Submission received March 17, 1987 regarding Proplast I,  
Proplast II, Proplast HA sent pursuant to Part V of the Medical Devices  
Regulations.  
Submission Numbers MSO17487 to MSO22187 have been assigned to these  
devices…262  
[226] Nancy Shadeed reviewed the submission and prepared a report. She determined that the  
submission should be treated as incomplete. This conclusion arose from the large number of  
devices for which an application was made and the difficulty in segregating the data applicable  
to each of them:  
This submission consists of many types of devices, whose purpose is to provide  
an improved implantable composition of material which promotes ingrowth of  
normal body tissue.  
259 Exhibit 48 at p. 3  
260 Evidence of Nancy Shadeed (May 23, 2019) at p. 11  
261 Ibid at p. 11  
262 Exhibit 12 at T. 5 and Exhibit 14 (1987 Vitek Proplast Submission Dockets) at p. 41  
Page: 78  
Since the submission consists of many devices, the manufacturer should be  
informed that separate applications should be made for each different indication  
of use. A Master File can be used for Quality Assurance, plant description,  
manufacturing process, microbiological safety and biocompatibility studies.263  
[227] The foundation for this problem is underscored by the overview report prepared by  
Christopher K. Ober which identifies differences in the various types of Proplast. Under the  
heading: “The absence of common elements in the chemical and physical properties of the  
various types and forms of ProplastTM” it notes:  
As a result of the differences in composition of the different ProplastTM types and  
forms and the strategies for combining ProplastTM with other materials, there are  
many different kinds of “Proplast” with many different property sets. The  
chemical and physical properties of the various types of ProplastTM depend upon:  
a) The chemical composition including choice of filler.  
b) The physical structure, porosity and the organization of the filler.  
c) Details of the manufacturing process [no one knows what this is].  
d) The nature of the substrate of which ProplastTM is bonded.  
e) The mechanical loading.  
f) Duration implantation.  
Polymers, including ProplastTM are known to age differently, mechanically and  
physically depending on the loads they are exposed to.  
In order to determine the causes of failure of the various types, forms and designs  
of devices manufactured from ProplastTM it would be necessary to analyse each  
one individually because of the variables listed above.264  
[228] In her Reviewer’s Report, Nancy Shadeed concluded:  
This submission should be rejected and the comments will reflect that a Master  
File should be prepared on the sections that are common to all types of devices,  
and a separate application for each different indication of use.265  
[229] The report prepared by Nancy Shadeed was taken up and considered at a submission  
meeting which took place on May 26, 1987. The minutes of that meeting note the issue, the  
recommendation of Nancy Shadeed and the decision made:  
263 Ibid at T. 7 (Reviewer's Report, May 25, 1987) and Exhibit 14 (1987 Vitek Proplast Submission Dockets) at p. 40  
264 Exhibit 8 (Expert Report of Dr. Christopher K. Ober, August 24, 2018) at pp. 8-9  
265 Exhibit 12 at T. 7 and Exhibit 14 (1987 Vitek Proplast Submission Dockets) at p. 40  
Page: 79  
Proplast I, Proplast II, Proplast HA:  
Submission consists of many types of devices whose purpose is to provide an  
improved implantable composition of material which promotes ingrowth of  
normal body tissue. As there are a number of different indications for use I feel  
this should be divided into a Master File and a submission submitted for each  
indication for use.  
Recommend we reject with detailed letter explaining our requirements.  
DECISION: Reject-send letter with detailed explanation of what is missing and  
what should be included. Advise that a Master File would be a benefit.266  
[230] The Reviewer’s Report completed by Nancy Shadeed noted that testing had been  
undertaken and included the observation:  
The devices are sold non-sterile but evidence that the device is sterile and safe are  
not adequately presented. Biocompatability tests are a 2 year study done on  
Beagle dogs. No physical testing is presented on the device. Clinical studies are  
performed on a total of 499 cases, with a success rate of 97%. Packaging and  
labelling are adequate.267  
[231] Nirmala Chopra indicated in her evidence that she had concerns. She noted that Pierre  
Blais was concerned with the use of Teflon but this was a general or generic concern. She had  
advised Nancy Shadeed to speak to Pierre Blais but there was no record that this had ever taken  
place. In her evidence Nancy Shadeed said this did not happen. Nirmala Chopra made no effort  
to discuss this submission or the use of Teflon in Proplast with Pierre Blais at the time this  
submission was being considered268  
[232] Be that as it may, a Note to File made by Nancy Shadeed after the submission meeting of  
May 26, 1987 makes clear these concerns were not the basis for the rejection. The submission  
was found to be incomplete because the submissions for the various and different Proplast  
products were lumped together. The information could not be disaggregated and associated  
separately with each of the individual devices:  
The reason for rejecting this submission is that it contains 40 types of devices. A  
good description of how each works is not given. It is too confusing to have all of  
these devices lumped together so that we are suggesting they prepare a Master  
File and then submit separate applications for each indication of use269  
266 Exhibit 21 at p. 2  
267 Exhibit 12 at T. 7 and Exhibit 14 (1987 Vitek Proplast Submission Dockets) at p. 40  
268 Transcript of Nirmala Chopra (April 24, 2019) at pp. 71-72 and 101-102  
269 Exhibit 14 (1987 Vitek Proplast Submission Dockets) at p. 36  
Page: 80  
[233] The decision was communicated to Vitek Inc. through a letter dated May 29, 1987, which  
said, in part:  
This is in regard to your submission numbers MSO17487 to MSO 22187 received  
March 17, 1987 regarding Proplast I, Proplast II and Proplast HA. The  
information submitted to establish safety and efficacy of the device as required by  
Section 36 of the Medical Devices Regulations has been reviewed and is  
considered to be incomplete.270  
[234] As required by the decision which had been taken, a detailed explanation was included  
with the letter. It said:  
Please resubmit complete information as described in the guideline, with  
particular attention to the following:  
1. The submission presented consists of many devices that have different  
indications for use. In order to facilitate the evaluation process, separate  
applications should be made for each indication of use. A Master File can be  
prepared for Sections 7 through 11 and 14 where company procedures,  
components and materials are identical from one model to another. The  
Master File may be referred to in subsequent submissions.  
2. Performance characteristics should be specified for each device.  
3. Engineering drawings should be provided for each type of device.  
4. Devices which are supplied non-sterile should include all information related  
to the recommended sterilization procedure that results in a sterile pyrogen-  
free device.  
4. [sic] Physical testing for each type of device, should include test procedures  
and criteria of acceptability for all tests.271  
[235] Subsequently, by letter dated July 13, 1987, the submissions that had been made were  
returned to Vitek Inc.272  
[236] A second submission was made in 1988. In the interim Vitek Inc. sought advice and  
assistance from the premarket section of Health and Welfare Canada. In preparing to resubmit,  
on March 1, 1988, Gene L. Fagelson, Quality Assurance Manager, Vitek Inc. spoke on the  
telephone with Marc-Andre Cote, an evaluator with the premarket section of Health and Welfare  
Canada, who made a note to file:  
270 Exhibit 12 at T. 8 and Exhibit 14 (1987 Vitek Proplast Submission Dockets) at p. 34  
271 Exhibit 12 at T. 8 and Exhibit 14 (1987 Vitek Proplast Submission Dockets) at p. 35  
272 Ibid at T. 9 and Exhibit 14 (1987 Vitek Proplast Submission Dockets) at p. 21  
Page: 81  
Upon discussion with Mr. Fagelson [phone number included] on March 1, 1988,  
it was agreed that, due to the complexity of the file and to past rejection of the  
submission, a visit to Ottawa would be the best course of action. He will arrange  
an appointment with Mrs. Chopra and present his submissions in person.273  
[237] The proposed meeting took place on March 15, 1988. A follow-up letter was written by  
Gene L. Fagelson to Nirmala Chopra. It was delivered with samples of the packaging to be used  
and of the product with more material to be provided. The letter suggests that the company  
understood the problem that was the basis of the earlier rejection:  
This letter is a follow-up on our conversation of 15 March. At that time, I  
promised to have to you the revised submission which breaks our total product  
mix into like groupings.274  
[238] The second submission (or resubmission) was received by Health and Welfare Canada on  
April 26, 1988.275 Nirmala Chopra assigned responsibility for the review of this submission to  
Dr. Richard Lawuyi. She left shortly thereafter and was not part of the review or consideration of  
these applications. Richard Lawuyi is not a medical doctor. He has a PhD. in organic chemistry  
from Carleton University. After receiving his PhD. he spent one year in a post-doctoral program  
at Agriculture Canada. From there he became a research scientist at Forintek Canada, an agency  
funded by the federal government looking to improve “forestry products” by adding polymer  
resin particles and increasing durability by soaking the wood in polymers. In 1986 he took a  
position with the University of Manitoba as a research associate. He held other positions but in  
1988 joined the Medical Devices Bureau.  
[239] Richard Lawuyi had not been there very long when the 1988 submission made by Vitek  
Inc. was given to him for review. He recalled that the workload was heavy and that when he  
arrived there was a significant backlog. Richard Lawuyi was asked if he was familiar with a  
memorandum, dated March 8, 1988, prepared by W.J. Welsh, the Acting Chief, Pre-Market  
Division, Bureau of Radiation and Medical Devices. He did not recall seeing it at the time but  
did recollect it being discussed at a meeting that he attended. The “Welsh Memo” was the  
subject of discussion through the course of the trial. It was a response to the backlog and delay in  
processing applications for Notices of Compliance:  
Pre-Market Review  
In an attempt to speed-up the pre-market review process, the following  
modifications are being implemented. Submissions for “simple” devices (e.g.  
Non-electronic drug delivery systems) will be assessed to determine reasonable  
assurance of safety (toxicity, biocompatibility, sterility, etc.). Efficacy and clinical  
aspects will not be assessed in detail. Malfunction of this type of device should  
273 Exhibit 14 (1987 Vitek Proplast Submission Dockets) at p. 16  
274 Ibid at p. 3  
275 Exhibit 16 (1988 Vitek Proplast Submission Dockets) at p.1  
Page: 82  
not precipitate a life-threatening situation since the device itself is not therapeutic.  
Problems would more likely be user rather than device related.  
Minor deficiencies will not result in the notice of compliance being delayed.  
Rather such requests for additional information will be made in the letter which  
accompanies the notice of compliance, and will be for the purpose of “completing  
our files”. Should a manufacturer not co-operate within a reasonable period of  
time, we will have to be more insistent with the next submission received from  
him.276  
[240] This document was the source of some debate. Could it be an indication of a systemic  
effort to speed up the process at the cost of a proper and complete review? Should it be taken as  
implying a willingness to obfuscate and a failure to properly consider the acceptability of the  
testing done to demonstrate the safety and efficacy of medical devices for which Notices of  
Compliance were being sought? The point was made, and I accept, that while this was an effort  
to contribute to the expediting of the review of certain applications it had no effect in respect of  
Vitek Proplast Implants. The memorandum is conditioned. It is to apply only to “simple  
devices”. It was accepted by all parties that the Vitek Proplast products could not be categorized  
as “simple devices”. There is nothing in the evidence that suggests that this memorandum was, in  
any way, brought to bear on the consideration of whether Notices of Compliance should be  
issued in respect of any of these “devices”.  
[241] It was about this time that another of the documents which originated with Pierre Blais,  
and where the authenticity was questioned by the Crown, could have come into play. Pierre Blais  
said that on April 28, 1987 he gave a paper entitled “Frangible, Degradable and Dispersible  
Implant Materials” to a group of medical professionals at a “Critical Care ‘87” conference at a  
convention centre in Hamilton, Ontario. To my reading, this is a document which contains  
general statements without data or proof. The opening paragraph makes the point:  
Detailed long term studies often reveal widely used implant variables that lack  
stability. Many such substances have remained in commerce because they fulfil a  
need and adverse reactions are tolerated. With the passage of time and with  
increasing usage, bothersome complications become expectations and no longer  
attract attention. These substances are now being encountered in new forms and  
novel products which placed greater demands on the constituents. Changes in  
physical properties are more noticeable and less tolerable. Degradation products  
appear sooner and in greater quantities. Leachables and metabolites often have  
pharmacologic effects complicating the management of conditions for which the  
implant was prescribed in the first place.277  
[242] This begs many questions: What studies? Which widely used implants? What substances  
remain in commerce to fill a need? What new forms and novel products? And so on. The paper  
276 Exhibit 12 at T. 31, Exhibit 56 at T. 6  
277 Exhibit 34 v. 1, T. 81 and Exhibit 73 T. 6  
Page: 83  
does refer to Proplast as “a controversial material found in many implant systems” and as a  
composite product that has “been of concern since the 1970’s”.278  
[243] The Crown says the document should not be relied on. Before a scientist employed by the  
Crown publishes or speaks to a paper, it must be approved by senior management.279 There is a  
form to be completed and signed. There was, in the record, such a form which purported to be  
the requisite approval for this paper. But is it? The paper and the form were produced by counsel  
for the Plaintiff to Justice Firestone as an enclosure to an email delivered at 1:05 AM on Friday,  
October 26, 2018, in preparation for a pretrial that was to be held later that day and to counsel for  
the Crown “…as quickly as I could after receiving it at midnight”.280  
[244] The Crown, in reviewing its files, found an approval form for another paper, this one  
entitled; “Future of Lasers in Critical Care”.281 Both this one and the form said to be the approval  
for the paper “Frangible, Degradable and Dispersible Implant Materials” were given to the  
forensic document experts to review. The problem is that when one of the approval forms is  
transferred to a plastic film and laid over the other, the bottom halves, the part of the page with  
the signatures and dates written into the form as well as other handwriting, printing and  
extraneous markings, match exactly. It was apparent that one was copied from the other.  
[245] Since only one of them has been found in the historic files of the Crown a reasonable  
inference is that it is the other one, the one produced by Pierre Blais late in the lead up to the trial  
(“Frangible, Degradable and Dispersible Implant Materials”), that is a copy.  
[246] There is in the Record an “incomplete bibliography” of “articles, reports, and other  
similar projects” attributed to Pierre Blais and attached as an exhibit to an Affidavit sworn by  
him in this action, on June 6, 2018.282 The bibliography refers to the paper “Future of Lasers in  
Critical Care” as having been a Keynote Lecture at the Critical Care ’87 symposium in Hamilton  
on April 28, 1987. It appears that the same paper was given at a similar symposium in Toronto at  
some other time during 1987. The bibliography also lists the paper “Frangible, Degradable and  
Dispersible Implant Materials” as having been given in Hamilton in the “Proceedings of Critical  
Care ‘87” on April 27-28, 1987. However, the program for that conference makes no reference to  
it.283 Although counsel advised Justice Firestone that this paper was also given in similar lectures  
during 1987 in Toronto and Edmonton the bibliography makes no reference to those  
presentations. The email delivering the paper to Justice Firestone indicated that the paper was  
“published in the Proceedings of a Symposium on Emergency and Critical Care organized by the  
Hamilton Hospitals in 1987”284 but those proceeding are not, so far as I am aware, included in  
the record of this trial. Similarly, there is a “Project Area Review” for the premarket program  
that was co-ordinated by Nirmala Chopra. It is dated January 18, 1988 and under heading “G.  
278 Ibid at pp. 6 and 10  
279 Affidavit of Pierre Blais sworn June 6, 2018 at para. 6  
280 Exhibit 34 v. 1 T. 81  
281 Exhibit 73 T. 7  
282 Affidavit of Pierre Blais, sworn June 6, 2018 at Exhibit 2  
283 Exhibit 79 (Forensic Laboratory Report, June 17, 2019) at T. A (Proceedings Book).  
284 Exhibit 34 v. 1 T. 81  
Page: 84  
1987-88 Reports” lists among other things “Journal publications”, “proceedings”, “papers” and  
“lectures”. The list includes, by reference to April 28, 1987, the paper “Future of Lasers in  
Critical Care” but makes no reference to the paper, “Frangible, Degradable and Dispersible  
Implant Materials”.  
[247] On the balance of probabilities, for the purposes of this trial and from the record  
produced here, I find that the approval form for the paper “Frangible, Degradable and  
Dispersible Implant Materials” was constructed by copying what was a proper approval of the  
paper “Future of Lasers in Critical Care.”  
[248] I wish to be clear about the appropriate implications to be taken from this finding.  
[249] There is, I suppose, the possibility of a benign explanation for the falsifying of the  
approval form. None was offered. More importantly, I am not prepared out-of-hand and based  
solely on this determination to ignore or take as false all the evidence provided by Pierre Blais.  
He was a long-time employee of Health and Welfare Canada and, despite some difficulty,  
particularly around his departure was, his employment reviews suggest, a valued one. What is  
appropriate is to weigh his evidence carefully against what others have said where that evidence  
appears to be probative and helpful to the Court in deciding the issues.  
[250] By way of example, on being shown that the paper “Frangible, Degradable and  
Dispersible Implant Materials” was not referred to in the program of the Critical Care ’87  
symposium, Pierre Blais said, for the first time, this was not a paper but a “workshop”. It was  
suggested there was another list that would show it. None was forthcoming. When it was pointed  
out to Pierre Blais that the “Project Area Review” made no reference to the that paper, Pierre  
Blais suggested he had not reviewed the document. If he had, he would have caught the  
omission. I do not accept either of these explanations. There is nothing that confirms these out-  
of-hand attempts at clarification.  
[251] In any case, the paper “Frangible, Degradable and Dispersible Implant Materials” is of  
little assistance. The email sent by counsel for the Plaintiff to the attention of Mr. Justice  
Firestone suggests the failure to produce this paper as an indication of serious failures by the  
Crown and as indicative of knowledge that required the Crown to act. Its failure to do so is taken  
as a confirmation of its negligence. The email says:  
This Paper demonstrates that:  
1. HC gave public presentations about hazardous products like Proplast;  
2. HC was fully aware of the injury potential and problems the products posed;  
3. HC routinely released gave technical information [sic] to hospitals about  
hazards and protection of Patient Safety on request by Hospitals, including the  
presentation of clinical rounds and lectures;  
4. HC’s Executive Officers reviewed, edited and gave formal authorization for  
teaching seminars and public symposia on these and related issues; and  
Page: 85  
5. The Attached EHCX Approval Document evidenced Executive actual,  
detailed and specific knowledge of specific Hazards from these papers.285  
[252] The paper does none of these things. As it is, there is doubt as to whether it was presented  
and whether it was approved. In the absence of approval there is nothing to say that it came to  
the attention of senior management at Health and Welfare Canada but, in any event, general  
statements that a product is “controversial” and “been of concern since the 1970’s” even said in  
the midst of a paper expressing a broader concern about the tendency of an array of products to  
degrade is not enough to support the listed inferences or to require regulators to act in some  
specific way. It could be said that, from the perspective of the Plaintiff, appropriate action was  
taken. As will become apparent and, as already noted, the applications for Notices of  
Compliance were, for the most part, refused. In this case the paper, if delivered, was to a small  
group of professionals. There is no demonstration that it was broadly distributed.  
[253] I return to Richard Lawuyi and his review of the 1988 submissions made in support of the  
applications for Notices of Compliance in respect of the Vitek Proplast products. In this case,  
unlike the submission made in 1987 the application was treated as complete and a review of the  
substance undertaken. This is not to say that the problem identified by Nancy Shadeed did not  
continue. The submission was comprised of 20 binders seeking Notices of Compliance for 51  
Vitek Proplast devices. Proplast taken on its own is not a device; it is a material. Thus, the need  
for separate applications for each of the 51 devices. Consistent with the concern raised in respect  
of the 1987 application there was, in 1988, a Master File. The expectation of Nancy Shadeed was  
that such a file would deal with the issues common to all the applications, leaving the device-  
specific issues to separate binders dealing the separate applications. Of the 20 volumes there are  
two more that are of immediate interest: one deals with “TM Joint Implants”286 and the other  
with “Block and Sheeting”.287  
[254] The Master File did not satisfy the purpose set for it. The principal concern in any  
application is, on the one hand, the safety of the device being considered and, on the other hand,  
its efficacy. A large measure of the information directed to these questions originates with testing  
where animals are the subjects, and clinical testing on humans. This is something that would  
require consideration directed to each device. At a minimum it would be plain what was being  
relied on to demonstrate the safety and efficacy of each of the devices that were the subject of a  
request for the issuance of a Notice of Compliance. That was not the case with this submission.  
The Master File is where the testing is reported. This is done by reliance on the tests done on  
beagle dogs and reported in 1975. The submission summarizes the test as follows:  
Both porous and non-porous forms of Proplast were tested in, Beagle dogs for two  
years. Cylindrical porous Proplast’s and flat plated non-porous Proplast were  
implemented in the femurs of separate groups of dogs. A group in which U.S.P.  
Plastic Standard coupons were implanted and a sham control group were run  
285 Ibid  
286 Exhibit 15 v. 1 at pp. 227-359  
287 Ibid at pp. 360-444  
Page: 86  
concurrently. Each group consisted of eight beagle dogs, four male and four  
female equalized to mean the group weights.  
No findings of toxicological significance were evident in this general observation,  
ophthalmology, bodyweight, hematology and clinical chemistry data, or in the  
necropsy and histopathological examinations. …288  
[255] It does not take much to see that this does not assist in understanding the variable impacts  
that could occur in hip, knee, ophthalmology, facial reconstruction or temporomandibular joint  
applications. The remaining parts of this segment of the Master File, the only place the test  
results are reported, contain a bibliography which groups the work into:  
(1) Oral and Maxillofacial Surgerywhich included “maxillary retrusion” described  
as a “dento- facial deformity”, “protracted mandibular dislocation”,  
osteotomies, chin implants, meniscus replacement, ankylosis, severe  
malocclusion and bird-face appearance, three wall osseous defectsand other  
issues;289  
(2) Plastic and Reconstructive Surgerywhich included “Effects of Stress on  
Healing Wounds” “Soft Tissue Response to Blood Impregnated Proplast”  
“Proplast Reconstruction of the Lower Sternum” “Clinical Experiences with  
Proplast As Implant” “Proplast, a Porous Implant for Contour Restoration”,  
“Synthetic Materials in Orbital and Surrounding Tissue” as well as other papers290  
(3) “Orthopedic and Hand Surgery” which included the use of a  
polytetrafluoroethylene/vitreous carbon porous material used as an alternative to  
acrylic for hip endoprosthesis fixation, a study comparing acrylic cement, Proplast  
and porous coated Co-Cr-Mo in a loadbearing canine tibia model; a study of a  
prosthesis coating material used in clinical and experimental surgery including  
femoral head prostheses, cruciate ligament appliances, augmenting devices of the  
alveolar ridge, zygomatic process and mental bone, heart valve stabilization and  
tracheal prostheses; a study examining implant stabilization in terms of the  
interaction between the surface of an implant and adjacent tissue as governed by  
four postulated key parameters; the examination of the proplast prosthetic stent as  
used as a replacement for the cruciate ligament of the knee; a study looking at the  
use of forty-five stemless Proplast-covered silicone rubber trapezium implants in  
respect of forty patients after trapeziectomy for either osteoarthritis, rheumatoid  
arthritis or trauma;291  
288 Ibid at p. 14  
289 Ibid at pp. 24-34  
290 Ibid at pp. 34-38  
291 Ibid at pp. 38-51  
Page: 87  
(4) “Gynecology” which included a preliminary study of “oviduct occlusion” and the  
prevention of adhesions in baboons and “oviduct occlusions” following the  
implantation of Proplast;292  
(5) “Oto-Rhino-Laryngology” which included the use of Proplast in a series of  
osteoplastic frontal sinus operations using the osteoplastic flap technique and the  
implanting of this synthetic material; the use of a total alloplastic ear prosthesis  
consisting of Teflon and pyrolytic graphite in three patients; an evaluation of  
Proplast as a new alloplastic material for use in head and neck reconstructive  
surgery; an evaluation of Proplast as a self-stabilizing alloplastic material in ear  
surgery (33 patients) and in facial reconstructive surgery (11 patients); the  
removal at revision surgery of 16 Proplast and 52 Plastipore prostheses examined  
histologically and the findings illustrated;293  
(6) “Ophthamology” which included testing in rabbits of Proplast for corneal  
tolerance and acceptance; two cases of late reconstruction of the orbit in which  
there had been moderate disruption of orbital anatomy; visual rehabilitation in  
otherwise blind individuals through use of the Girard keratoprosthesis; the use of  
hemi-spherical implants of Proplast 15 mm. in diameter that had been fashioned  
similar to Castroviejo’s implants; the testing of Proplast as primary spherical  
implant after unilateral enucleation in albino rabbits;294 and  
(7) “General Interest” which included an “experiment” intended to evaluate the  
tensile strength of PTFEC after aging in two solutions at different temperatures; a  
study of femoral stems of Thompson prostheses coated with Proplast using  
conventional histological examination, scanning electron microscopy and electron  
probe microanalysis in “successful” firm implants and in “loose” clinically  
unsuccessful implants; the description a rapid in vitro screening protocol to guide  
selection and monitoring of polymers for implant or extracorporeal applications; a  
poste presentation of the “porosity determination” of “a low modulus implant  
material” (presumably proplast).295  
[256] The breadth of these areas and the variable subject matter of these studies makes clear the  
difficulty in associating a particular medical device for which a Notice of Compliance was being  
sought with the tests and work that would support its safety and efficacy.  
[257] This section of the Master File also presents pages summarizing the number of  
“craniofacial augmentation” surgeries carried out at a variety of different locations296 as well as  
one page providing a similar summary (only numerical, no analysis) of otoplasties carried out297  
292 Ibid at p. 51  
293 Ibid at pp. 51-60  
294 Ibid at pp. 60-62  
295 Ibid at pp. 62-64  
296 Ibid at pp. 82-95  
297 Ibid at p. 96  
Page: 88  
and another one page numerical summary of “PROPLAST IMPLANT MATERIAL, Causes of  
Failure, All Followed Cases (1970-December 1977)”.298 This is followed by another 128 pages  
of material. The purpose of it is hard to discern. There is an index to the Master File but no pages  
dividing the topics these subsequent pages were to deal with. What is clear is that there is  
nothing that would allow for an appreciation of anything being specifically directed to any one or  
group of the 51 devices being considered for Notices of Compliance. Presumably they were to be  
applied to all of those devices underscoring that the objection of Nancy Shadeed to the earlier  
1987 submission remained.  
[258] This concern was manifest in the response of Richard Lawuyi to the second (the 1988)  
submission. The issue was recalled at a submission meeting held on June 21, 1988:  
Initial submission was made in May 1983 and rejected in 1987 due to lack of  
efficacy data and large number of devices all lumped together…299  
[259] There was a further submission meeting on June 27, 1988. The Minutes of the meeting  
note the range of applications:  
There are 51 devices and 20 binders altogether. Proplast is an implant material  
used in facial and cosmetic surgery and for diverse bone irregularities. They are  
made in all shapes and sizes ranging from the angular zygomatic arches to quarter  
moon -shaped chin augmentation. They can also be trimmed by the surgeon to fit  
individual needs (blocks, sheets, laminated, non-laminated, porous to non porous).  
All used in augmentation of facial bony contours.  
[260] The presence of a significant literature and the claims made based on that literature was  
referred to:  
There are extensive literature reports and publications some dating back to 1976  
all giving favourable commendation to Proplast. They all claimed it is efficient  
and safe. For example out of 499 craniofacial and otological procedures there are  
13 failures resulting from: 5 chin infections, 2 chin postoperative trauma, 1 nasal  
post operative trauma, 1 zygomatic infection, 4 extrusion followed by  
replacement.  
[261] This is followed by the expression of concern for the lack of detail and appropriate  
testing:  
General comments on Quality Assurance, no numbers, figures, charts or  
indications of audits.  
General comments on testing methods, no details or numbers. Reflux destructive  
test, lateral pull tests.  
298 Ibid at p. 97  
299 Exhibit 56 T.8 (Minutes of Submission Meeting, June 21, 1988)  
Page: 89  
[262] And a decision made asking for the purpose of each of the devices and raising questions  
as to the efficacy of some of them:  
Decision check the intended use for each. If for ligament reconstruction determine  
the efficacy of the device.300  
[263] Two days later on June 29, 1988, Richard Lawuyi spoke to Gene Fagelson who had  
telephoned inquiring as to the status of the 1988 submission. Richard Lawuyi advised Gene  
Fagelson that the Medical Devices Bureau was not happy with how the submission had been  
organized and that the Medical Devices Bureau would be requesting additional data to support  
the safety and efficacy of Vitek Inc.’s orthopaedic devices. Gene Fagelson advised that Vitek  
Inc. had not received approval from the United States Food and Drug Administration for  
Proplast-based orthopaedic implants.301 Richard Lawuyi described orthopaedic devices as those  
intended for use in the skeletal system, which were distinct from other types of devices in the  
1988 submission, such as facial implants, which were indicated for use in soft tissue. Richard  
Lawuyi identified Vitek Inc.’s temporomandibular joint implants as orthopaedic devices.302  
[264] There was another submission meeting on July 5, 1988. The concern for efficacy was  
repeated in respect of the broader category of orthopaedic uses (as I understand it ligament repair  
is a subset of orthopaedic surgery) and for those uses the concern for better information  
substantiated:  
On the basis of my conversation with Mr. Fagelson and the FDA, it appears that  
the orthopedic devices have not been allowed on the market in North America  
because evidence of the safety and efficacy of these devices is lacking. I am  
therefore recommending an F. I. [Further Information] for the orthopedic  
ones…303  
[265] On July 26, 1988 the issue arose at a further submission meeting. As the Minutes report:  
Mr. Gene Fagelson called. He wanted to know what more is required for safety  
and efficacy as in our FI letter. I [Richard Lawuyi] told him results from the  
literature submitted are not adequate.304  
[266] A decision was taken to refer that issue to the “Clinical Advisory Division”. On August  
16, 1988, the Clinical Advisory Division reported back. It confirmed the problem but it also  
shows that the Clinical Advisory Division had done some of the work that was expected from  
Vitek Inc, as the applicant for the Notices of Compliance. The Clinical Advisory Division had  
300 Exhibit 17 (Minutes of Submission Meeting, June 27, 1988), Exhibit 56 T. 9  
301 Transcript of Richard Lawuyi (May 28, 2019) at pp. 30-31; Exhibit 16 at p. 97; Agreed Statement of Facts at  
para. 106  
302 Ibid at p. 31  
303 Exhibit 47 T. 2 (Minutes of Submission Meeting, July 5, 1988)  
304 Ibid at T. 3 (Minutes of Submission Meeting, July 28, 1988  
Page: 90  
separated out and grouped the 32 various devices for which information supporting efficacy was  
required:  
There are 8 types of Proplast T.M joint devices in this submission. The  
manufacturer has collected a large number of journal articles and other  
publications on clinical experience with these devices. Some of these articles may  
be useful to demonstrate the safety and effectiveness of Vitek devices. However,  
the manufacturer will first have to choose which articles they wish to associate  
with each type of device. The clinical data presented must be generated by the use  
of the Vitek Devices, or the manufacturer must make the claim that their device is  
identical to the devices described in the publications. The present format of this  
submission is not useful for the demonstration of safety and effectiveness of the  
devices for which the notice of compliance is being requested. A copy of our  
Guide for reporting of clinical trial data could be sent to the manufacturer.305  
[267] This was followed by another submission meeting, this one on August 22, 1988, which  
considered the comments received from the Clinical Criteria Division:  
Proplast T.M.J. (Temporo Mandibular Joint) Implant  
Comments have now been received from the Clinical Criteria Division. There are  
8 types of TMJ implants.  
1. Vitek has been asked to sort out the literature reports and publications into  
groups and then associate each group with the corresponding group of  
devices.  
2. It will be necessary to clarify specifically which device(s) was used in the  
above publication(s).  
Recommend: a FI [Further Information] to this effect.  
Decision: send letter to request clarifications as recommended by Dr. K .  
Magwood306  
[268] The results and the conclusion of the premarket review section were communicated to  
Vitek, Inc. by a letter dated September 2, 1988. It makes clear that the concern with respect to  
efforts of the company to demonstrate safety and efficacy, now narrowed to the various forms of  
temporomandibular joint implants, remained:  
Dear Mr. Fagelson:  
305 Exhibit 16 p. 86 (Letter from K. Magwood to WJ. Welsh, August 16, 1988)  
306 Exhibit 56 T. 13 at p. 4  
Page: 91  
This is further to my letter of July 7, 1988, and the telephone conversation  
(Lawuyi and Fagelson) regarding the Proplast T.M. Joint Implant (submission  
numbered MSO39288 to MSO40188).  
Your submission has again been carefully evaluated in order to establish safety  
and efficacy for the subject device the following is required:  
- Because there are really eight different types of devices in this submission,  
the literature articles and publications on clinical experience will have to  
be broken down into eight different groups. Each group will then have to  
be associated with the corresponding device and the model designation as  
well. (A sample copy of our breakdown is attached).  
- identification of the articles and publication on clinical experience that  
directly refer to Vitek products.  
If you have any further questions please contact this office.307  
[269] The applications for Vitek Poplast TMJ implants were refused.  
[270] The Submissions of the Plaintiff identify substantive concerns with the review of these  
submissions:  
the insufficiency of any physical testing on “the device”  
concerns with the “beagle studies”  
the methodology of the surgeries and whether they contribute to an understanding  
of the applicable safety and efficacy.  
[271] As the Submissions of the Plaintiff note, Richard Lawuyi dealt with each of them:  
He did not agree there had been no physical testing (“I saw some physical  
testing….”) and went on to say: “...but it does not affect anything because I did  
not [review] it in detail. We asked Mr. Fagelson to reorganize it so we can  
examine all the details, all the experimental details, both physical and biological  
tests”.308  
With respect to the beagle studies he noted: “They did indicate that it was to  
replace the femur. It was for biocompatibility aspect [sic]. Even in that, you  
cannot infer anything about the bio functionality which is even more important in  
307 Exhibit 16 p. 81 (Letter L. Boulay to Gene L. Fagelson, September 2, 1988), Exhibit 56 T. 14 and Exhibit 58 T. 2  
308 Transcript of Richard Lawuyi (May 28, 2019) at p. 70  
Page: 92  
this case.”309 Richard Lawuyi added: “…usually in studies like this when we  
don’t understand, we have to ask them to explain how it was done.”310  
As for the surgical methodology Richard Lawuyi said: “It doesn’t help in the  
evaluation. It may be for the doctors who are doing the implant, doing the surgical  
procedures” but that document has nothing to do with safety or efficacy  
evaluations. “There’s lots of stuff to read that we don’t think have any impact on  
the evaluation and the results, but still, there are somewhere that we looked at.” 311  
[272] What these comments and the response confirm is the overarching concern for the lack of  
proper organization of the material that made up the submission. It was impossible to assess  
them properly because it was unclear how the information was to be applied and to which of the  
devices any particular piece of that evidence was relevant. This was the principal concern raised  
by Nancy Shadeed in her earlier evaluation albeit one that dealt only with the completeness of  
the submissions.  
[273] Following his June 29, 1988 telephone conversation with Gene L. Fagelson, Richard  
Lawuyi prepared a note to file:  
Mr. Fagelson called. Inquired about the status of his submission. I told him that  
you would be hearing from us within a month. I also informed him that we would  
be requiring more data to support safety and efficacy of the orthopedic devices.  
To this he replied that he is no longer interested in the orthopedic ones because  
the company has not sold any in North America and they could not get approval  
from FDA anyway.312  
[274] There were applications for Notices of Compliance for devices other than the 32  
identified as TMJ implants. Among those accounted for in this way were the applications for  
“Block and Sheeting”. As understood by Richard Lawuyi these applications were for uses other  
than as temporomandibular joint implants. They were for facial implants only.  
[275] The day following his telephone conversation with Gene Fagelson (June 30, 1988)  
Richard Lawuyi called Dr. Carl A. Larson of the FDA. In his evidence at trial, Richard Lawuyi  
outlined the substance of this call:  
The subject was the TMJ from Vitek. He was telling me, he was informing me  
that approval had not been given to the orthopedic Proplast devices but  
permission has been given to market the facial implants only. He realized that  
309 Transcript of Richard Lawuyi (May 29, 2019) at p. 39  
310 Ibid at p. 40  
311 Transcript of Richard Lawuyi (May 27, 2019) at p. 113  
312 Exhibit 16 at p. 81 (Note to File)  
Page: 93  
they were having problems with the TMJ or the orthopedic devices. That was one  
of our main evidences that we should not give any approval.313  
[276] It was after the call to Dr. Carl A. Larson that the submission meeting of July 5, 1988  
took place. Following the recommendation that Further Information be requested for orthopaedic  
devices, the Minutes of that meeting go on to indicate that a Notice of Compliance will be  
recommended “for facial implants only”. This is followed by the decision taken at the meeting:  
Decision: Issue Notice of Compliance facial implants and get letter from  
manufacturer to the effect that the devices will not be indicated for ligament  
repair.314  
[277] It seems that the letter confirming the advice that Vitek Inc was no longer interested in  
obtaining Notices of Compliance for orthopaedic uses was not sought or provided. Certainly,  
Richard Lawuyi did not know if such a letter was sent.  
[278] He did not write one.315 Instead, on July 7, 1988 W. J. Welsh A/Chief, Premarket  
Division sent a letter to Gene L. Fagelson Quality Assurance, Vitek Inc.:  
Dear Mr. Fagelson:  
This is in reference to your submissions numbered MSO37188 to MSO42288  
received April 26, 1988, concerning Proplast’s I, II and HA submitted pursuant to  
Part V of the Medical Device Regulations.  
Your submissions have been carefully reviewed and the following devices  
recommended for issuance of Notices of Compliance. The relevant documents  
will be forwarded under separate cover.  
Preform Facial Implants MSO37688 to MSO38788  
Facial Blocks and Sheeting to MSO41588  
However, current data including clinical studies, clearly demonstrating safety and  
efficacy will be required for the following devices:  
Anaform Hip Prostheses  
TM Joint Implants  
Total and Partial Ossicular Replacement Prostheses  
313 Transcript of Richard Lawuyi (May 28, 2019) at p. 39  
314 Exhibit 47 at T. 2 (Minutes of Submission Meeting, July 5, 1988)  
315 Transcript of Richard Lawuyi (May 29, 2019) at p. 55  
Page: 94  
Tissue Cushion Pad  
Trochanter Pad  
Staple Cushion Pad  
Trapezium Implants  
Please find enclosed a copy of the Medical Devices Regulations and Guide to aid  
in preparing the required information.316  
[279] On July 11, 1988, as enclosures with a covering letter, Notices of Compliance were  
delivered. The letter made clear the limits understood, by Health and Welfare Canada to apply.  
The opening paragraph stating:  
Dear Mr. Fagelson:  
This is a reference to your submissions, numbered MSO37688 to MSO38788 and  
MSO40288 to MSO41588, of April 25, 1980, received April 26, 1988, concerning  
the Preform Facial Implant and the Facial Blocks and Sheeting submitted  
pursuant to Part V of the Medical Devices Regulations. The information supplied  
has been reviewed and is considered adequate to issue the notices of  
compliance.317  
[280] As described in this letter, the devices subject to the Notice of Compliance that was  
enclosed, were associated with “facial” work. Consistent with this understanding,  
correspondence from Health and Welfare Canada refers to the grouping as “Facial Block and  
Sheeting”. This can be read as attaching the adjective “facial” to both “Block” and “Sheeting”.  
On a preliminary look one might wonder if this was accurate. For the devices labelled as  
“Block”, that word is preceded by the word “facial” where the product is identified as “Sheeting”  
the modifier “facial” does not appear in this correspondence.318 The “Purpose” for these devices  
be they “Block” or “Sheeting” is described in the Submission supporting the request for issuance  
of Notices of Compliance as:  
Proplast Block and Sheeting Implant material are intended for augmentation of  
either hard or soft tissue and bony contours where congenital or acquired  
deficiencies exist. The highly porous nature of the material allows for stabilization  
of the implant by tissue ingrowth.319  
[281] Read on its own this perceives the use of this material for more than just facial  
applications. The adjective “facial” does not appear. However, what follows suggests otherwise.  
316 Exhibit 16 p. 93  
317 Exhibit 16 p. 88, Exhibit 12 T. 32 p. 13 and Exhibit 56 T. 18 (after the green sheet)  
318 Exhibit 15 (Vitek Proplast Submission 1988) v. 1 at pp. 363-365  
319 Ibid at p. 366  
Page: 95  
On the pages of the Submission, that come after this statement of purpose, are sheets dealing  
with some or all of the applicable devices, some identified as “Sheeting”, others as “Block” and  
one as a “zygomatic implant”320. Each one has a heading “Indication” which stands as an  
indication of the use to which the particular device(s) might be put. All but one are indicated for  
a use related to the “augmentation of facial bony contour” [Emphasis added]. The exception is  
“PROPLAST I ULTRA – THIN SHEETING” which is “especially indicated for microsurgery  
applications (such as middle ear surgery) where delicate bone and certain cartilage reconstruction  
is required…”321 When the more general statement of purpose is read in conjunction with these  
more specific indications of the use to which these devices could be put it becomes clear that  
both “Block” and “Sheeting”, as the subject of Notices of Compliance, were only to be  
associated with “facial” uses. There was no suggestion that these Notices of Compliance  
contemplated the use of Block and Sheeting for orthopaedic uses. This understanding  
underscores the significance of the acknowledgment apparently expressed by Gene L. Fagelson  
that Vitek Inc. was no longer interested in approval of orthopaedic implants and the advice that  
the Food and Drug Administration had not approved Proplast for such purposes.  
[282] The materials that make up the Submission include what were referred to as “product  
monographs”. These are documents which describe the product, uses and protocols that govern  
the use of the devices to which it applies. The monograph is to be included with each product  
item sold to advise the user, presumably the physician and surgeon, as to the nature, prospective  
uses and limitations of the device. At that point they will stand apart from the rest of the  
Submission. Once it is understood that a Notice of Compliance is not an approval, just an  
authorization to enter the market, it becomes apparent that these documents do not legislate use  
but provide guidance as to how the device might assist patients and how to make use of it. The  
monograph is a guideline, it is not legislation or regulation.  
[283] In this case no monograph was provided for each of the devices that fell within the  
grouping of “Facial Block and Sheeting”. Put differently, the product monograph does not deal  
with the individual devices for which Notices of Compliance were sought and granted. There  
was one general document evidently intended to be used for all of them. It begins with a caution:  
CAUTION: INDIVIDUALS USING THE IMPLANTS DESCRIBED HEREIN  
MUST HAVE PROPER TRAINING AND EXPERIENCE FOR SUCCESSFUL  
PROCEDURAL RESULTS. PROCEDURAL SUCCESS IS SIGNIFICANTLY  
TECHNIQUE DEPENDENT. 322  
[284] This makes clear that those who used these devices needed to have experience to  
understand and make judgments about the use of the product. The “General Description” begins  
by repeating the statement of purpose albeit with reference only to Block and not to Sheeting  
and, as before without the apparent limitation of the word “facial”:  
320 Ibid: sheeting at pp. 368, 370, 372, 374, 382, 386, 388, 390, 392, 394, 396; facial block at pp. 380, 384, 398 and  
zygomatic implant at p. 376  
321 Ibid at p. 386  
322 Ibid at p. 417  
Page: 96  
General Description  
Ultra porous ProplastR I (gray) II (white) and Proplast-HATM (Hydroxylapatite)  
(white) in block form are intended for augmentation for either hard or soft tissue  
and bony contours where congenital or acquired deficiencies exist the highly  
porous nature of Proplast implant materials can permit stabilization of the  
impact by tissue ingrowth.  
[285] What comes thereafter concerns the three versions of Proplast which are used as a  
material in the manufacture of the devices being the various forms of Block and Sheeting that  
were issued Notices of Compliance. Here, there is a reference to the use of this material having  
been used in “temporomandibular and orthopaedic endoprostheses” as a coating:  
All types of Proplast implant materials are prepared in a similar manner from  
polytetrafluoroethylene (PTFE) and either vitreous carbon (Proplast I), alumina  
(Proplast II), or synthetic hydroxylapatite (Proplast-HA).  
The pore size distribution for standard Proplast I, II or HA implant materials is  
approximately 50 to 400 micrometers. The pore volume of Proplast implant  
materials comprises 70 to 90% of the total material volume.  
In vitro biotoxicity studies in animal models have shown Proplast implant  
materials to be free from observable systemic or cytotoxic effects.  
Numerous uses of Proplast implant materials have been widely documented in  
general skeletal reconstructive and cosmetic applications, maxillofacial  
augmentation, middle ear surgery, and as a stabilizing coating for  
temporomandibular and orthopedic endoprostheses.323  
[Emphasis added]  
[286] What follows is a description of each of the three Proplast materials covered in this  
submission: “About Proplast I”, “About Proplast II” and “About Proplast-HA  
(Hydroxylapatite)”. The use of each of the three is described as “exclusively for surgical  
implantation” with the performance characteristic of “implant stabilization by tissue  
ingrowth”.324 Each of the three descriptions carries on to outline some of the physical properties  
of the Proplast material being considered.  
[287] In the product monograph, after these descriptions of the Proplast materials, there is a  
section with the title: “Advantages of Proplast Implant Materials”. This outlines those  
advantages as seen by Vitek Inc. as the applicant for the Notices of Compliance.  
323 Ibid at p. 417-418  
324 Ibid at pp. 418-419  
Page: 97  
[288] What none of this does is to distinguish between any specific uses to which any or all of  
these devices be they “Block” or “Sheeting” might be put to. This is not surprising. “Block” and  
“Sheeting” by their nature are not set for any particular use. Surgeons do not implant “blocks” or  
“sheets”. These materials are to be formed or shaped for the particular use to which they are to  
be put. This is confirmed by the fact there are other “devices” that are the subject of the  
Submission, specifically “preformed” for use as “TM Joint Implants”325 and “Preform Facial  
Implants.”326 As already noted the former were not issued Notices of Compliance. The latter  
were. This is consistent with the understanding of Richard Lawuyi that the Notices of  
Compliance recognized the use of Proplast in facial implants but not orthopaedic ones.  
[289] What this speaks to is that the applications for Notices of Compliance for “Block” and  
“Sheeting” recognize that these “devices” are not directed to a narrow or specific purpose. Their  
purpose is general in nature. These “devices” are “materials” which require refinement before  
they are used or implanted. This is different than the applications in respect of “TM Joint  
Implants”327 and “Preform Facial Implants”. The purpose of those “devices” is directed towards  
assisting with or even resolving particular concerns: facial needs and problems with  
temporomandibular joints. This difference is demonstrated by the statements of purpose found  
within the three applicable product monographs.  
[290] As has already been noted the stated purpose for “Block” and "Sheeting” as found in the  
product monograph included as part of the submission is broad. They are to be used “for the  
augmentation of either hard or soft tissue and bony contours where congenital or acquired  
deficiencies exist.”328 This is to be compared to the purpose or use to which “TM Joint Implants”  
and “Preform Facial Implants” are to be put. The proposed product monograph for the first  
contains several possible statements, each one directed to a more specific use than the one  
utilized for “Block and Sheeting:  
The Total TMJ Implant System is intended for use in patients with severe  
malformation and/or destruction of the TMJ anatomy resulting from advanced  
rheumatoid arthritis, severe osteoarthritis, ankylosis, fumors, and/or condylar  
resorption following surgery for internal derangement. Such joints may exhibit  
significant functional impairment resulting in pain, restricted motion, joint laxity,  
vertical deficiency and/or malocclusion and thus pose difficult problems in joint  
reconstruction.329  
And  
Vitek PROPLASTR TMJ Interpositional Implants are available for post-  
meniscectomy use for separating articular surfaces. Such separation may reduce  
325 Ibid at pp. 227-359  
326 Ibid at pp. 445-570  
327 Ibid at pp. 227-359  
328 Ibid at p. 417  
329 Ibid at p. 328  
Page: 98  
pain, may improve function, may reduce hypermobility, and may compensate for  
a limited decrease in condylar height.330  
And  
PROPLAST sheeting laminated to non-porous Teflon may be indicated in  
temporomandibular joint surgery where the meniscus is absent or removed. It may  
avoid bone to bone apposition and ingrowth with fibrous tissue may provide disc-  
like viscoelastic behaviour. (19) The lamination is also available with polyaramid  
reinforced Teflon; this form may be selected for those cases where the surgeon  
believes added implant strength is desired.331  
[291] Even the “Cautions” which are at the beginning of the product monographs demonstrate  
this difference. Where the one offered in respect of “Block and Sheeting” is short and to the  
point (see para. [282] above) those proposed for or related to “TM Joint Implants” are more  
complicated and specific to TMJ implants:  
CAUTION: SURGERY OF THE TEMPOROMANDIBULAR JOINT, (TMJ) IS,  
BY ITS NATURE, COMPLEX AND CARRIES A CERTAIN LEVEL OF RISK.  
INDIVIDUALS USING THE IMPLANTS DESCRIBED HEREIN MUST  
HAVE APPROPRIATE TRAINING AND EXPERIENCE FOR SUCCESSFUL  
PROCEDURE RESULTS. TMJ RECONSTRUCTION REQUIRES A HIGH  
DEGREE OF SKILL, FAMILIARITY WITH JOINT ANATOMY AND  
MECHANICS AS WELL AS BIOMATERIALS AND THE USE OF THE  
RECOMMENDED INSTRUMENTATION. THE LONG-TERM ACCESS THE  
TOTAL TMJ IMPLANT PROCEDURE IS SIGNIFICANTLY TECHNIQUE  
DEPENDENT. RESULTS MAY BE COMPROMISED BY PREVIOUS  
MULTIPLE JOINT OPERATIONS332  
330 Ibid at p. 329  
331 Ibid at p. 330  
332 Exhibit 15 (Vitek Proplast Submission 1988) v. 1 at p. 328.  
Within the form of product monograph contained within the submission dealing with TM Joint Implants there are  
other statements of caution as follows, all more directed and detailed than the one in respect of “Block and Sheeting:  
CAUTION: SURGERY OF THE TEMPOROMANDIBULAR JOINT IS, BY ITS NATURE,  
COMPLEX AND CARRIES A CERTAIN LEVEL OF RISK. INDIVIDUALS USING THE  
IMPLANTS DESCRIBED HEREIN MUST HAVE APPROPRIATE TRAINING AND  
EXPERIENCE. TM JOINT RECONSTRUCTION REQUIRES HIGH DEGREE SKILL,  
FAMILIARITY WITH JOINT ANATOMY AND MECHANICS AS WELL AS  
BIOMATERIALS. THIS PROCEDURE IS SIGNIFICANTLY TECHNIQUE  
DEPENDENT. (at p. 329)  
And  
Page: 99  
[292] In the proposed product monograph dealing with “Preform Facial Implants” there is no  
caution offered. Presumably this is because there was no need for one. This would occur in  
circumstances where the implantation is not that complex or technique dependent. The use is  
more simply stated but nonetheless driven to specific purposes:  
Preformed shapes of Proplast are available for use in augmentation and  
reconstruction of the chin, zygoma, nose, peri-orbital rim and ear.333  
[293] As it developed, the Notices of Compliance for “TM Joint Implants” were refused. Those  
requested for “Preformed Facial Implants” and “Block and Sheeting” were issued. The idea that  
granting Notices of Compliance for Block and Sheeting allowed for their use as  
temporomandibular joint implants when applications for Notices of Compliance for products  
specifically dedicated to that purpose were rejected is a circumstance where the general would be  
able to do what the specific cannot. In the context of treating a delicate and sensitive condition,  
where the devices involved are developed at the same time, using the same material, this does  
not seem sensible or intended. The question that may remain is whether those referring to or  
relying on these Notices of Compliance can reasonably be expected to understand the broader  
context of their issuance or whether the product monograph which would accompany the  
purchase of the product, in this case “Block” or “Sheeting” was to be a self-standing document,  
to be read and understood on its own, and whether, being read that way, it demonstrated that  
those devices could be considered for the use as temporomandibular joint implants. I say the  
question “may remain” because its relevance depends on whether the temporomandibular joint  
implants received by any of the members of the class originated from “Block” or “Sheeting”, the  
“devices” that were the subject of the Notices of Compliance that were issued. If, in fact, the  
CAUTION: ALTHOUGH THE YOUNGER FEMALE PATIENT APPEARS TO BE THE  
PREDOMINANT PRESENTER WITH INTRACTABLE TMJ DISCOMFORT AND  
IMPAIRMENT IN SPITE OF CONSERVATIVE THERAPY, ALL AFFECTED PATIENTS  
CAN EXPERIENCE CONDYLAR HEAD REMODELLING AND/OR RESORPTION OF  
UNKNOWN ETIOLOGY WHETHER OR NOT IMPLANT SURGERY IS PERFORMED. A  
SMALL PERCENTAGE OF FEMALE PATIENTS SEEM TO UNDERGO CONDYLAR  
HEAD RESORPTION WHICH RESULTS IN PROGRESSIVE CLASS II OCCLUSION  
DEVELOPMENT AS A RESULT OF TMJ LOADING OF ANY KIND.(11) THIS  
RESORPTION AND PROGRESSIVE CLASS II DEVELOPMENT CAN BE ONGOING  
WHEN THE PATIENT PRESENTS FOR TMJ EVALUATION OR CAN OCCUR AFTER  
IMPLANT PLACEMENT IN SUSCEPTIBLE INDIVIDUALS. TMJ SURGERY SHOULD BE  
AVOIDED IN PATIENTS WITH A HISTORY OF CLASS II BITE CHANGE. CONDYLAR  
REMODELING OR RESORPTION CAN COMPROMISE THE RESULT OF SURGERY,  
AND, IN SOME CASES, FURTHER SURGICAL INTERVENTION WILL BE REQUIRED. IN  
GENERAL, DISCECTOMY AND IMPLANT PLACEMENT SHOULD BE AVOIDED IF  
POSSIBLE (at P. 330).  
And  
CAUTION: USE OF THIS IMPLANT SHOULD BE RESERVED AS AN OPTION ONLY  
WHEN MORE CONSERVATIVE MEDICAL AND/OR SURGICAL OPTIONS HAVE BEEN  
EXHAUSTED OR ARE NOT INDICATED (at p. 330).  
333 Ibid at p. 550  
Page: 100  
temporomandibular joint implants utilized were among those dealt with through the request for  
recognition of “TM Joint Implants”, the patients involved received implants that were not to be  
used. It would not be possible to rely on the approval of Block and Sheeting as demonstrating the  
presence of a duty of care, owed by the Crown or, if there otherwise was one, demonstrating it  
had been breached by the Crown. There is no evidence that any patient that could be a member  
of the class was implanted with “Block” or “Sheeting”, after those devices were in receipt of a  
Notice of Compliance.  
[294] The cross-examination of Elliot Wayne Tunis describes how orders, on his behalf, were  
made:  
Q. This photocopy of a page and a notebook appears to document the ordering of,  
at least for the entry dated September 26, 1985, document:  
The Ordering of a Proplast VITEK 913.46, Fossa, TMJ Prothesis Correct?  
A. Yes.  
Q. I am inferring from that that means that two of these implants were ordered  
and received?  
A. That’s what I would assume, yes.  
MR. NEWLAND: And would this be consistent with your experience when you  
wish to implant some Proplast Teflon that you ask the hospital for certain kind of  
implant?  
A. Only if it was something out of the ordinary. If it was an interpositional  
implant it was kept in stock. If it was a fossa prosthesis it would be ordered  
specifically for a certain case.  
Q. I see. Is your evidence that it was basically you would have obtained these  
Proplast implants in one of two ways, either the hospital kept a continuous supply  
of Proplast implant? That would be the first way, correct?  
A. Yes.  
Q. And the second way would be that if it were a Proplast implant that was  
somewhat less routine, you would specifically ask someone at the hospital if they  
could order it?  
A. Yes.  
Page: 101  
Q. And so a Proplast implant, to replace the data disk in a meniscectomy, would  
fall into the former kind of category; is that fair?  
A. The one that was kept in stock?  
Q. Yes.  
A. Yes.  
Q. And so a fossa prosthesis was something less ordinary and you would make a  
specific order for it?  
A. Yes  
Q. And that order, I think. I don’t know if I got this right, that order would be  
made to someone in the hospital administration?  
A. I would have told the head nurse of our OR, because she was in charge  
obtaining materials we needed. And she would then take that to purchasing or  
whoever would be in charge of obtaining those items. I don’t know exactly where  
it went. 334  
[295] This exchange was followed by the exhibiting of a “Photocopy of document containing  
entry dated September 26, 1985 (the ordering of a Proplast Vitek 913.46 fossa, TMJ prothesis)”.  
[296] What is plain from this is that Wayne Elliot Tunis used the devices specifically made to  
be used as temporomandibular joint implants. They would not have received Notices of  
Compliance but the hospital with which he was associated purchased them and he implanted  
them. There is no evidence that he made use of the more general devices, that is, Block and  
Sheeting, which he, or someone under his direction, would have had to form and shape so it  
could be used as an implant to the temporomandibular joint.  
[297] For his part Daniel Tomlak was asked about the product that he used:  
Q. Okay. And I thought I heard you say this morning that it had not been FDA  
approved. Is that specifically in relation to the, the interpositional implant or the  
pre-cut device?  
A. Well, again the interpositional implant refers – that’s generic. You put in a  
Proplast, silastic sheeting, that’s interpositional. Vitek came out with an  
interpositional material that was a laminate and that was Teflon-Proplast. That  
was not approved until ’83.335  
334 Transcript, Cross-Examination of Elliot Wayne Tunis on his affidavit sworn August 1, 2007 at pp. 61-64  
335 Transcript of Dr. Daniel Tomlak (May 21, 2019) at p. 4  
Page: 102  
And  
Q. And so, would it be fair to say what you were taught, and your view at the time  
was that Proplast was the best material available for a disc replacement surgery.  
A. Yes. The laminate. The Teflon-Proplast.336  
[298] This comment says nothing about which Vitek Proplast product Daniel Tomlak used after  
his return to Canada. It does not matter. 1983 is the year the Daniel Tomlak went to Thunder  
Bay. 1986 is the year he attended the conference and, as a result of what he was told in informal  
discussions, stopped using Proplast-Teflon. It was not until 1988 that Proplast Block and  
Sheeting were granted Notices of Compliance. This happened at a time before the second  
submission seeking Notices of Compliance and, accordingly before such notices were issued in  
respect of Block and Sheeting. In his evidence, Daniel Tomlak indicated that he did not concern  
himself with whether or not the product he was using had received a Notice of Compliance. He  
relied on the reputations of the distributor (Instrumentarium Inc.) and its representative. This is  
contrary to the statement made in the Submissions of the Plaintiff where it is said that Daniel  
Tomlak believed that because the interpositional implants were on the Canadian market they had  
undergone an assessment of safety and efficacy by Health and Welfare Canada before being  
approved.337 This idea is contrary to the evidence as I understand it. First medical devices are  
never “approved”. They receive Notices of Compliance meaning that that they have complied  
with the requirements for obtaining such status. Second, Notices of Compliance for  
“interpositional implants” were refused. It may be that Daniel Tomlak believed Notices of  
Compliance had been issued but it was not because of the actions of the regulator that he was  
mistaken, it was because as a result of his faith in Instrumentarium Inc. and its representative he  
believed the necessary work had been done.  
[299] There is no other evidence from any other doctor who implanted patients in Canada and,  
if there are any who did, which device they used, in particular, whether they purchased it as  
Block or Sheeting to be shaped and formed.  
[300] What about the patients? The representative plaintiff did not testify. Some parts of her  
medical records were filed and received by the Court, on consent.338 This material reveals that  
during 1988, Kathryn Anne Taylor had a total joint reconstruction using a “Kent-Vitek  
prosthesis”. I note that at the time of the first motion considering certification, the motion judge  
was of the understanding that the implant the representative plaintiff had received was a “Vitek  
TMJ implant. This was important because it distinguished this case from the one commenced  
by Kevan Drady. In that action the claim was struck out, in part because Kevan Drady was  
unable to identify the specific kind of implant he had received. Kathryn Anne Taylor could but it  
was not one of those that had been the subject of a request for a Notice of Compliance. To put it  
simply, the implant received by Kathryn Anne Taylor was not a “Vitek TMJ Implant”. It was a  
336 Ibid at p. 7  
337 Submissions of the Plaintiff at para. 57  
338 Exhibit 46 and Exhibit 72 (which is a transcript of the Examination for Discovery including exhibits to that  
discovery which, in turn, include additional medical records)  
Page: 103  
“Kent-Vitek Implant”. Whatever the difference, it appears that the implant she received may not  
have been one of the group of implants used to identify the class. There are among the implants  
considered some which include in the name that identifies them the two letters “VK”.  
Presumably this indicates “Vitek/Kent but nothing was said that compares “VK” implants to  
“Kent-Vitek”. This raises the question as to whether Kathryn Anne Taylor is part of the class.  
This issue was raised by the Crown at the first determination of the application for certification:  
Counsel for the Attorney General submitted also that Ms Taylor should be  
rejected as a representative plaintiff because there was evidence that her implants  
contain a unique component and no evidence that it and other Vitek TMJ implants  
have any common characteristics. I do not accept the submission. The witness  
who referred to the conjunction of Proplast and another component as being  
unique in his experience, did not find that it would, or could, be significant in  
relation to the issues in the action. His evidence was that it was not "typical" - a  
concept that is not part of the criteria for certification in this jurisdiction. By itself,  
I do not consider this evidence to be sufficient to disqualify Ms Taylor as a  
representative of the class. This finding is without prejudice to any motion the  
defendants might bring - with supporting affidavit evidence - in the future for the  
examination or discovery of other class members.339  
[301] In any case, the function and impact of this implant placed in the jaw of Kathryn Anne  
Taylor was monitored during the years that followed. In a report dated October 1, 1997, Dr.  
Gerard Baker observed that:  
So far, there has been no clinical or radiographic evidence of local bone and soft  
tissue reaction to the Kent-Vitek prosthesis.340  
[302] She was seen again by Dr. Gordon Baker on October 5, 2000:  
She has an artificial joint being Pro plast Teflon [sic]. She has been monitored  
since 1994 for this appliance. We have made the elective decision based on her  
excellent function, not to remove this device and replace it with another type of  
joint. It is equivocal as to whether the problem today is related to the joint itself,  
or the trigeminal neuralgia or a combination.341  
[303] The next year, 2001 she was seen by Dr. Allan Gordon. He reviewed the medication she  
was taking, but his Note also comments:  
339 Taylor v. Canada (Health), 2007 CanLII 36645 (ON SC), 285 DLR (4th) 296, 49 CPC (6th) 36, [2007] OJ No  
3312 (QL), 160 ACWS (3d) 385 at para. 39  
340 Transcript of the Examination for Discovery of Kathryn Anne Taylor (April 25, 2017) at Exhibit 4  
341 Ibid at Exhibit 5  
Page: 104  
She does want to see Dr. Baker because she did have an injury to her jaw in  
England.342  
[304] Kathryn Anne Taylor was seen by Dr. Sidney Fireman. By letter dated March 23, 2012,  
he reported on “Hitachi Cone Beam CT Imaging” completed on March 16, 2012. In part he  
wrote:  
A larger field was employed to allow for an assessment of the TMJ’s; this was of  
special interest to me and the patient as I had examined her 10 years previously  
for this. Advanced degenerative joint disease is evident in the left joint. There is  
no suggestion of complication with respect to the attachment of the metal plate on  
the right side. Good bone volume is suggested in the edentulous 33-30 for site. I  
have screened the data set; there is no evidence of significant abnormality in those  
parts of the volume not presented.343  
[305] What is plain from this is that the representative plaintiff received a TMJ Implant  
prosthesis which included Proplast in its composition and which was developed or credited, not  
just to Vitek Inc. but also to Dr. J.N. Kent who was referred to, during the trial, as a colleague of  
Charles Homsy.344 Kathryn Anne Taylor was not implanted with “facial Block and Sheeting”.  
Moreover, the prosthesis which she received was other than the Vitek Inc. products for which  
applications for Noticed of Compliance were applied for and refused.  
[306] Trudy Tallon testified. In 1985 she underwent surgery that included the insertion of a  
Vitek Proplast TMJ implant. Whether this was cut from Block and Sheeting that was the subject  
of a Notice of Compliance or was a preformed implant for which no Notice of Compliance was  
issued is not determinable from the evidence that was provided. It was implanted by Dr. William  
Dowhos, one of the two surgeons in Thunder Bay with whom Daniel Tomlak worked while  
there. 345 William Dowhos is the doctor that directed Daniel Tomlak to the head operating nurse  
for the purpose of seeing about the purchase of the implants. For a brief period, Daniel Tomlak  
oversaw the care of Trudy Tallon.346 In the period since, Trudy Tallon has suffered.347 The  
implant was taken out in 1988. This being so, as with the patients implanted by Daniel Tomlak,  
the implanting took place before the Notice of Compliance was granted to Proplast Block and  
Sheeting.  
[307] At the time the implant was taken out, the oral surgeon, Dr. Symington, told her that the  
implant had shattered and that he was unable to extract all the resulting particulate.348 She has  
undergone a bilateral total joint replacement at the Baylor Medical Center, in Texas. Even with  
342 Ibid at Exhibit 6  
343 Ibid at Exhibit 8  
344 This is different than the information provided to the Court of Appeal where the device implanted in the  
representative plaintiff was referred to as a “Vitek TMJ implant” (see: Taylor v. Canada (Attorney General), supra  
(fn. 35) at para. 6)  
345 Transcript of Trudy Tallon (April 5, 2019) at p. 10  
346 Ibid at p. 14  
347 Ibid at pp. 13-16  
348 Ibid at pp. 17 and 24  
Page: 105  
this, she remains in a state of pain.349 Trudy Tallon is reliant on a soft liquid diet.350 At some  
point in the early 1990’s she and her husband, David Bullough, who also gave evidence in this  
trial, contacted the United States Food and Drug Administration. They were referred to Health  
and Welfare Canada. Generally, over the course of 1994-2001 each year, they telephoned Health  
and Welfare Canada in order to obtain information on Vitek Proplast implants. 351 They were  
told that there was nothing that was available but that Health and Welfare Canada would contact  
them if any information was received. These telephone calls represent direct contact between  
Trudy Tallon and Health and Welfare Canada.  
[308] Brenda Birinyi appeared as a witness at the trial. Over the years she has had multiple  
temporomandibular joint surgeries, many of them in the United States and, latterly, in Canada.  
Each of the surgeries conducted in the United States were performed by Larry Wolford, referred  
to by Daniel Tomlak as among the top five oral maxillofacial surgeons in the United States.  
Among those surgeries, on December 30, 1986, Larry Wolford performed a “Right  
temporomandibular joint arthroplasty and insertion of [a] Proplast-Teflon implant”.352 The  
device failed and had to be removed. Larry Wolford replaced it with a silastic implant. He did  
this on February 5, 1987 but it also failed and was removed on August 1, 1987.353 It is difficult to  
see how a Canadian regulator, in this case Health and Welfare Canada, could be liable, in any  
way, for the implanting of a maxillofacial device in the United States, under the auspices of the  
regulatory scheme in place in that country. In the circumstances of this case, it cannot be.  
[309] On February 17, 1989, at the Credit Valley Hospital in Mississauga, Ontario, a Proplast-  
polyethylene glenoid fossa implant was placed in the temporomandibular joint of Brenda Birinyi  
by Dr. D. S. Psutka. The prosthesis utilized was identified in the following sentences:  
Attention was returned to the preauricular wound using the 6 mm medium right  
sided proplast-polyethylene glenoid fossa implant, the implant was impregnated  
with Ancef solution and then custom trimmed with a large scalpel. After  
idealizing the fit and customizing the fit of this implant with trimming and  
banding the prosthesis was secured to the zygomatic arch with a circum-  
zygomatic 26 gauge wire and a 2 mm Titanium bone screw. This gave excellent  
stabilization of the glenoid fossa prosthesis. Attention was then directed towards  
customizing the fit of the condylar prosthesis. The Vitech [sic] 45 mm right sided  
condyle was selected for this patient, benders were used to maximize the contact  
between the condylar prosthesis articular surface and of the articular surface of  
the glenoid fossa prosthesis.354  
[Emphasis added]  
349 Ibid at pp. 24-26, 30-31 and 33  
350 Ibid at p. 33  
351 Ibid at pp. 21-23 and see Transcript of David Bullough (April 5, 2019) at pp. 39-41  
352 Exhibit 25 T. 2A p. 7  
353 Transcript of Brenda Birinyi (April 25, 2019) at p. 91-94  
354 Exhibit 25 T. 3A (Operative Record, Feb. 17, 89) at p. 3  
Page: 106  
[310] This was not “Block” or “Sheeting”. The description is of a pre-cut, preformed implant  
specially directed to use as a temporomandibular joint implant. During the course of the same  
procedure “silastic sheeting” was used as part of the reconstructive arthroplasty performed on the  
left side:  
Using 0.6 silastic sheeting a custom silastic meniscus implant was fabricated and  
ligated to the zygomatic arch using 26 gauge wire.355  
[311] Silastic is not Proplast. Silastic sheeting is not Proplast sheeting. Silastic had been used  
prior to Proplast products. Proplast was thought to be an improvement because it provided better  
stability through the ingrowth of tissue once the implant was in place. Whatever was implanted  
as recorded in this quotation, it was not the “Sheeting” that was the subject of the Notices of  
Compliance issued to Vitek Proplast “facial Block and Sheeting”.  
[312] A second surgery was performed June 16, 1989. The work done included the “custom  
fabrication and installation [of] Vitek II glenoid fossa prothesis left TMJ” and “customization  
and installation Vitek II left condylar prothesis”. There is no reference to “Block” or “Sheeting”.  
I am unaware of any reference, in the Record of this proceeding to “Vitek II”. There is mention  
of “Proplast II” and to “VK II”. Regardless of any confusion this may appear to create, it is clear  
that the “custom fabrication” and “customizing” does not refer to remodelling using “Block” or  
“Sheeting” as the base. It refers to the “customizing” of a preformed Vitek Proplast  
temporomandibular implant.  
[313] There is no suggestion, in the evidence, that Brenda Birinyi or anyone on her behalf  
telephoned, spoke to or wrote to representatives of Health and Welfare Canada.  
[314] Katherine Madden was another patient who testified at the trial. Like Trudy Tallon and  
Brenda Birinyi she has had multiple procedures associated with her temporomandibular joint.  
She has, over the course of her life, undergone a total of 22 such surgeries.356 None of them  
involved Proplast. The medical records that were filed reveal that by December 11, 1987 she had  
already had four joint procedures. On that day, she had “a bilateral TMJ reconstruction including  
meniscectomy, silastic implants, dermal graphs to the joints bilaterally, and placement of arch  
bars”357 [Emphasis added]. She was discharged on December 15, 1987 but three days later, on  
December 18, 1987 the same surgeon, Dr. W. Dobrovolsky, operated again:  
OPERATION: Bilateral TMJ reconstruction including eminectomy, condylar  
shave, menisectomy, silastic fossa implant, with harvesting of dermal graphs from  
left buttock.  
355 Ibid at p. 2  
356 Transcript of Katherine Madden (April 25, 2019) at p. 17  
357 Exhibit 23 T. 4 (FINAL SUMMARY, Rept. date: 22, Feb. 88) p. 2  
Page: 107  
The area was copiously irrigated and soft tissue margins were trimmed. At this  
stage, silastic faucet implants were fit from within the silastic sheeting and  
attached to the superior aspect of the joint, namely the glenoid fossa via three  
lower screws through the zygomatic arch. The joints were functioned to ensure  
range of motion on the condylar head was within the confinds [sic] of silastic and  
the silastic was trimmed so as not to impinge on the ear canal.358  
[Emphasis added]  
[315] During 1988, it was proposed that Katherine Madden receive a Vitek Proplast Teflon  
implant. On the scheduled date Katherine Madden had strep throat and the surgery did not take  
place.359 She came under the care of Dr. D.S. Psutka, the same surgeon who operated on Brenda  
Birinyi at the Credit Valley Hospital. On December 9, 1988 he removed the implant placed by  
Dr. W. Dobrovolsky and replaced it with another also made of silastic sheeting:  
Silastic sheet material was then cut to fabricate a custom meniscus implant.360  
[316] Katherine Madden got embroiled in a debate as to the efficacy of Proplast implants. She  
attended a seminar in Oakland California about the dangers of Proplast.361 At the end of May  
1989, she was seen by D.S. Psutka. He “wanted to put the Vitek Proplast Teflon Implant into  
me.”362 Katherine Madden told the court that she advised D. S. Psutka of what she had learned at  
the conference. In his view as expressed by her, Katherine Madden had been “brainwashed”.363  
Katherine Madden went on to explain that two days after her appointment with D.S. Psutka, she,  
with the assistance of her mother, telephoned Health and Welfare Canada to warn them about the  
dangers “[w]ith the Silastic but also to inform them about the Proplast Teflon”.364 They raised  
Proplast even though Katherine Madden did not have a Proplast implant because she “didn’t  
want other people to suffer”.365 During the summer of 1989 they telephoned Health and Welfare  
Canada four times. They were put on to Dr.William Freeland. They were trying to “raise the  
alarm” with respect to Proplast and silastic. They made further calls to Health and Welfare  
Canada in 1990.366  
[317] During August 1990 Katherine Madden had a further surgery; this one in San Antonio  
Texas by Dr. Robert L. Christianson. The silastic implant and excess bone were removed and  
fresh prostheses implanted. In evidence she described this as a stock Morgan implant made of  
titanium and acrylic.367  
358 Ibid (OPERATIVE NOTE, Rept. date: 18/12/87) at pp. 1 and 3  
359 Transcript of Katherine Madden (April 25, 2019) at p. 21  
360Exhibit 23 T.5 (OPERATIVE RECORD, Date of Operation: Dec. 9, 1988) at p. 3  
361 Transcript of Katherine Madden (April 25, 2019) at pp. 39-42  
362 Ibid at at p. 43  
363 Ibid at p. 43  
364 Ibid at pp. 52-53  
365 Ibid at p. 72  
366 Ibid at p. 64  
367 Ibid at p. 65  
Page: 108  
[318] Following this surgery Katherine Madden and her mother made further efforts to  
communicate with Health and Welfare Canada. They wanted to “raise the alarm about the  
silastic and again about Proplastbecause of what they had learned from Robert L. Christianson.  
In response to a request made during that call they sent the material they had been given in  
Texas.368 There were responses. Katherine Madden received a fax about a warning in Canada.  
She could not recall what it said. She also could not recall but may have received a letter from  
the Medical Devices Bureau, dated October 28, 1994, which stated its purpose to be to inform  
the reader of “concerns with alloplastic TMJ implants”.369  
[319] Judy Munro received a Vitek Proplast implant. It was put in place, in Thunder Bay by  
William Dowhos. This took place in late 1985. Judy Munro was told that the implant was a  
“Teflon plate”. In evidence, at trial she said she “…didn’t really understand what that meant.”370  
Subsequent to her appearance, and with the consent of counsel for the Crown, an Operative  
Record in respect of this surgery was made an exhibit in this trial albeit under the name Judy  
Corbett. It was never reviewed by any witness. I am left to interpret it for myself. It includes the  
following sentence:  
The anterior portion was also cauterized and the Proplast interpositional placed,  
cut to fit properly and sutured with the use of 3-0 Silk burr holed being placed  
into the zygomatic arch.371  
[Emphasis added]  
[320] Daniel Tomlak referred to the term “interpositional” as generic (see para. [297] above):  
when something is placed between the two articulating bony structures (the condyle and the  
fossa) to replace the meniscus it is “interpositional”. It could be pre-cut for the purpose, still  
requiring some further cuts for proper fitting or it could be cut from Block or Sheeting. Thus, the  
description from the operative note is not helpful. If it was formed from Block or Sheeting; these  
“devices” were not, at the time subject to a Notice of Compliance. However, there is nothing to  
suggest the circumstances of Judy Munro were any different than those the patients implanted by  
Daniel Tomlak.  
[321] Judy Munro is an example of the limited impact this class action can have regardless of  
the ultimate result. There is nothing that suggests that Judy Munro was implanted with a device  
that had received a Notice of Compliance. Her complaints began immediately after the surgery.  
She continued to see her family doctor. She did not seek a second opinion from an oral surgeon  
as to her problems until 1993 when she visited the Mayo Clinic in Minnesota. On her return she  
saw both her family doctor and her dentist. Neither knew “anything about it.”372 I take “it” to  
refer to the recall that had taken place in 1990 and will be reviewed later in these reasons. This  
368 Ibid at pp. 69-71and Exhibit 23 T. 1  
369 Transcript of Katherine Madden (May 14, 2019) p. 26-27 and Exhibit 36  
370 Transcript of Judy Munro (April 3, 2019) at p. 2  
371 Exhibit 5  
372 Transcript of Judy Munro (April 3, 2019) at p. 9  
Page: 109  
leaves open the question of whether, and to what extent, the work of the various health  
professionals involved might have contributed to her difficulties. The issue is more acute in a  
situation such as this, where the liability to be imposed on the Crown, should the action succeed,  
is to be restricted to its proportionate share of the damage.  
[322] By this time the Health Protection Branch had set up a Medical Devices hotline. Judy  
Munro called that number. It seems that Judy Munro called a variety of individuals and  
eventually spoke to Jim Moore, described as a Compliance Officer with the Health Protection  
Branch. This resulted in a series of letters from the branch to a lawyer who had been retained by  
Judy Munro.373  
[323] Judith Anne Logan also testified. She received an implant on March 26, 1985 which is to  
say before any Notice of Compliance was issued. The surgery took place at the Chedoke-  
McMaster Hospital. At the outset of her evidence the question of which implant she had received  
was raised. This was well before the submissions seeking Notices of Compliance had been made.  
Judith Anne Logan had been the representative plaintiff in this action. Judith Anne Logan was  
implanted with a “Teflon Proplast meniscus [that] was then tailored to fit the fossa”.374 The  
reference to this implant as a “meniscus” that was “tailored” suggests that this was not “Block or  
Sheeting” but was a preformed meniscus replacement to be used as a temporomandibular joint  
implant and augmented to fit the patient.  
[324] The upshot is that there is no direct or specific evidence that any prospective class  
member was ever implanted with Block and Sheeting in a temporomandibular joint and, in any  
case, there is no evidence any patient received such an implant after either of Block or Sheeting  
had been issued a Notice of Compliance. This raises the question as to whether there is anyone  
who can claim negligence in the respect of the review and issuance of the Notices of  
Compliance.  
[325] Given the failure to identify a single person who received “Block” or “Sheeting” as a  
temporomandibular joint implant or a single professional (doctor or dentist) who implanted these  
materials, it does not matter what the product monograph says because no one has been  
identified as having been misled by it.  
[326] Even so, I go on to consider the alternative proposition.  
[327] On the assumption that there is a person who received, or a doctor who implanted, Block  
or Sheeting in a temporomandibular joint, what does the product monograph for Block and  
Sheeting say that misrepresents the circumstances and could have misled the reasonable reader?  
In this case the reader must surely be the health professionals, not the patients. This  
understanding was confirmed by the evidence of Nirmala Chopra who testified that the product  
373 Exhibits 1, 2, 3 and 4  
374 Transcript of Judith Anne Logan (May 16, 2019) at p. 35 referencing Exhibit 40 (Various Records of Dr. R.  
Harper) at p. 1  
Page: 110  
monograph was intended to go to the oral surgeon who “decides whether or not the  
contraindications apply to a particular patient”375  
[328] Pierre Blais in discussing “product warnings” said much the same thing:  
THE COURT: Well, can I just ask a question about this before you go on. These  
product warnings, I take were, we could be talking about two things that we’ve  
discussed, I suppose. One is the sort of Information Letters that have been sent  
out explaining concerns. Is that a product warning?  
A. No, no, Your Honour. A product warning is something that is built into the  
product itself. We call it generically, we call it a product insert. A product  
insert will have warnings just like a drug.  
THE COURT: Is this like drugs or like cigarettes?  
A. With cigarettes, yes, you're correct.  
THE COURT: All right, so these warnings would be, I take it, presented to the  
people who unpacked the device.  
A. They were part and parcel of the submission.  
THE COURT: Oh, I see. I mean, I’m sorry, this is something that the department  
that the premarketing people were told by the manufacturers as it came in.  
A. Yes.  
THE COURT: So is this what we’ve been referred to earlier as contraindications?  
A. Product warning has a very specific name in this business and it’s labeled – it  
establishes the limit of the product. The claims, what it can’t do, what it may do,  
how you may get around it to recover your patient....  
THE COURT: Sorry, what product can do?  
A. What it can do...  
THE COURT: Yeah.  
A. ...in terms of injury, how it is to be treated by a physician who encounters it as  
a problem, how the product could misbehave under some circumstances. In a  
way you could almost call it the birth certificate of a...  
THE COURT: Well...  
375 Evidence of Nirmala Chopra (April 11, 2019) at p. 146  
Page: 111  
A. ...product.  
THE COURT: ...let me just see if I understand what this actually is. This is some  
explanation of the limits of the product which are provided by the manufacturer  
distributor to the regulator at the time of submission is made under Part V?  
A. Yes.  
THE COURT: With the intention that if the Notice of Compliance is issued, that  
label will be passed on to whoever opens or looks at the package.  
A. Yes.  
THE COURT: And the person who opens and looks at the package would be  
presumably be the doctor or the hospital.  
A. Yes.  
THE COURT: Okay. To put it another way, we’re not anticipating here that the  
patient is going to open the package and read the label, it’s the doctor or the  
hospital or surgeon that’s going to do so.  
A. No, but that needs a small qualification.  
THE COURT: No, what? Sorry, no, yes, I’m right?  
A. The, the product insert or the instructions for use for most high-risk products  
do not reach the patient, ever.  
THE COURT: Just a minute.  
A. They stop at the physician.  
THE COURT: Okay. Sorry, it sounded like you want to keep going.  
A. Now, there is another document that is built into the product by the  
manufacturer which is supposed to be, what is the minimum that can be  
transmitted to the patient so as to be sure of safety and efficacy.  
THE COURT: And who is it that’s supposed to transmit that minimum material  
to the patient?  
A. The surgeon or the institution or the followup specialist, the nurse. There  
could be other professionals and paraprofessionals.  
THE COURT: Okay. I think I got it now. Thanks. Just a minute. Okay.  
Page: 112  
MR. LEGGE: Thank you, Your Honour376  
[329] In the Product Monograph prepared for “Block and Sheeting”, following its discussion of  
the three Proplast materials (“About Proplast I”, “About Proplast II” and “About Proplast-HA”),  
there is a review of the “Advantages of Proplast Implant Materials”. Among them is: “Carvable--  
easily sculpted to desired shapes with sharp scalpel”.377 This confirms that “Block” and  
“Sheeting” are not finished implants but materials to be shaped and sculpted. From there, the  
product monograph goes on and refers to “Indications” and “Contraindications” for the use of  
those materials. Among the “Contraindications” are the following:  
Proplast is NOT indicated for use in applications where the material will be  
subject to immediate postoperative compressive loading or in applications where  
there is insufficient underlying bone or tissue to prevent collapse of the implant in  
the event of external pressures,  
and  
Proplast is NOT indicated for use in filling voids on articulating bony surfaces.  
Proplast is not indicated to use as implant itself in weight-bearing or articulating  
joint applications where the implant itself would be subject to immediate post-  
operative compressive loading.  
[330] In their examinations, at trial, counsel for the Plaintiff were at some pains to demonstrate  
that those who implanted the TM Joint implants of concern were careful to instruct their patients  
that, for a period of time immediately after the surgery, care in eating should be taken to avoid  
any loading on the temporomandibular joint. Counsel for the Plaintiff rely on this to say that the  
direction found in the “Contraindication” was met. This understanding provides the foundation  
for the idea that, if a contraindication has been responded to the use to which the implant is put  
can be taken as authorized.  
[331] Surely, this is not the case.  
[332] The “Indications” found in the product monograph include:  
For use as an implant itself where augmentation of either hard or soft tissue is  
desired,  
and  
For augmentation of bony contour where congenital or acquired deficiencies  
exist,  
376 Transcript of Pierre Blais (May 1, 2019) at pp. 39-41. (There is a discussion with Pierre Blais concerning  
“Contraindications” in the Transcript of Pierre Blais (May 6, 2019) at pp. 86-87 but it does not contribute to an  
understanding of the limits or meaning of the word.)  
377 Exhibit 15 v. 1 p. 419  
Page: 113  
and  
For augmentation or stabilization by tissue in growth is desired.  
[333] If the premise is accepted, there need be no additional or continuing consideration by the  
manufacturers, distributors, hospitals or healthcare professionals as to whether any prospective  
use is appropriate for the product being considered. If the implant is to augment tissue or bone  
and will not result in any immediate post operative compressive loading and these indications are  
taken to be enough to confirm its use for any of the broad array of purposes these generalized  
statements may encompass, it no longer matters what the particular use may be: orthopaedic,  
facial, cosmetic or whatever. This conclusion does not fit where the regulatory scheme does not  
perceive the “approval” of anything:  
It must be noted that there is no authority or mechanism under the Food and  
Drugs Act to approve a medical device prior to its sale in Canada. It is the  
responsibility of the manufacturer to ensure that the regulatory requirements are  
met.378  
[334] During the course of the trial, the absence of authority to “approve” was acknowledged  
by all parties. A use which falls within the terms of an “Indication” and outside the parameters of  
a “Contraindication” is not thereby approved for that use. If it were otherwise, a regulator would  
be left in a circumstance where it could only provide Notices of Compliance to “new devices”  
for specific and directed uses. It would be a de facto (an actual, real and effective) approval. This  
would be contrary to the policy of attempting to make available to the public products that hold  
out the possibility of relief albeit while recognizing that there may remain a measure of risk (that  
is a balance between safety and efficacy). This understanding would place a responsibility on the  
regulator that the regulatory scheme does not allow for and remove, from the health  
professionals, obligations as to the appropriateness of treatments that it leaves to them.  
[335] This position promotes the question of what should be taken from the use of the words  
“Indications” and “Contraindications”. What do these words mean, in the circumstances that  
they are being used? No one was asked to explain their meaning as used in a product monograph.  
I turn to a dictionary for the “plain and ordinary” meaning:  
Indication: 1a: something that serves to indicate b: something that is indicated as  
advisable or necessary 2. the action of indicating.  
[336] To understand this definition requires a further understanding of the meaning of the word  
“indicate”:  
Indicate: 1a: to point out or point to b: to be a sign, symptom, or index of (the  
high fever indicates a serious condition) c. To demonstrate or suggest the  
378 Exhibit 48 (Guide to the Preparation of a Submission Pursuant to Part V of the Medical Devices Regulations) at  
p. 3  
Page: 114  
necessity or advisability of (indicated the need for a new school) 2. To state or  
express briefly (indicated a desire to cooperate)  
Contraindication: something (as a symptom or condition) that makes a particular  
treatment or procedure inadvisable.379  
[337] There is nothing in these meanings that point to anything being approved or prohibited.  
“Indications” point to things from a positive perspective; something is “advisable”. In this case it  
cannot be asserted that an implant made from Proplast Block or Sheeting was, from a medical  
point of view, “necessary” for the treatment of any person that required bone or tissue  
augmentation. No one has suggested there were no other treatment approaches available or that  
this was the only one that could, and would, succeed in respect of any of the problems associated  
with these issues. “Contraindication” looks at things from the negative perspective. The  
treatment is inadvisable where there will be immediate post operative compressive loading.  
Being inadvisable is not a prohibition. In the context of this case, that contraindication says only  
that one should be careful in using Proplast “Block” and “Sheeting” where such loading may  
exist. It does not say that this is the only risk in using this material; that is, that absent immediate  
post operative loading there is no risk to using it where tissue and bone augmentation is desired.  
[338] Accordingly, even if there was an identified party implanted with something “carved  
from” Proplast “Block” or “Sheeting”, the product monograph does not demonstrate a definitive  
determination that, with the Notices of Compliance being issued, the regulator was providing a  
systemic or blanket allowance for their use as temporomandibular joint implants.  
[339] Before leaving this area, it may be important to note that Richard Lawuyi, who was  
responsible for the review, never read the product monograph. He saw it as promotional material  
rather than as a document guiding the user as to its use and associated risks. How can we be sure  
that Richard Lawuyi properly evaluated the “safety and efficacy” of these products if he did not  
review this material? I note that the product monograph was not the only place in the submission  
that these statements of “Indication” and “Contraindication” occur. They are stated at the first  
page of the Submission concerning “Block and Sheeting” that comes after the Table of Contents  
and the list of applicable devices. That is to say they are repeated separately from the Product  
Monograph. They are part of the stated “Purpose” of these “devices”.380 There was no suggestion  
that Richard Lawuyi did not review and consider these statements in that context. They were  
specifically reviewed with him in the course of his being cross-examined.381  
[340] Among other things, this exchange establishes that the contents of the package in which  
medical devices are to be delivered includes statements that advise as to the limits to which the  
product should be put and that the advice is directed to medical professionals engaged in that  
379 These definitions come from Merriman Webster’s Collegiate Dictionary, Tenth Edition © 1993 Merriam-  
Webster, Incorporated  
380 Exhibit 15 v. 1 p. 366-367  
381 Transcript of Richard Lawuyi (May 28, 2019) at pp. 96  
Page: 115  
use. Product monographs are intended to be included in the packaging and do provide that  
advice. The covering letter to Gene L. Fagelson dated July 11, 1988 which enclosed the Notices  
of Compliance for “Facial Block and Sheeting” noted:  
Section 39 of the Medical Devices Regulations requires that all manufacturers  
submit samples of the product monograph, labels, package inserts, product  
brochures and file cards before the product is advertised or sold.382  
[341] The primary responsibility for the content of any product monograph lies with the  
manufacturer or distributor, that is the party seeking and requesting the issuance of a Notice of  
Compliance.  
[342] The claim that the Crown should be found to have been negligent rests not only on the  
allegation of error in respect of those Proplast products for which Notices of Compliance were  
issued but also in respect of those for which they were not. I return to the “special case” heard by  
the Court of Appeal and to its decision released July 6, 2012. In doing so I remind the reader  
that, at its root, this was a pleadings motion. The facts are to be taken as proved or capable of  
being proved:  
Ultimately, I come to this point. It is not clear to me that Ms. Taylor will at the  
end of the day succeed in making out a private law duty of care owed to her by  
Health and Welfare Canada. However, bearing in mind that at this stage the  
allegations must be assumed to be true and must be read generously, and also  
having regard to the dynamic nature of the jurisprudence, it is not plain and  
obvious that the claim as pleaded is bound to fail for want of a private law duty of  
care. The courtroom door cannot be closed to Ms. Taylor and the other members  
of the class at this stage.383  
[343] The decision of the Court of Appeal noted:  
Reading Ms. Taylor’s pleadings generously, they allege that between 1988 and  
1990 Health and Welfare Canada repeatedly misrepresented the safety of the  
implants Ms. Taylor and others received by wrongly representing that those  
implants had received a notice of compliance….384  
382 Exhibit 16 p. 88, Exhibit 12 T. 32 p. 13 and Exhibit 56 T. 18 (after the green sheet)  
383 Taylor v. Canada (Attorney General), supra (fn. 35) at para. 120  
384 Ibid at para. 110: The paragraph goes on:  
The pleadings further allege that when Health and Welfare Canada became aware of its  
misrepresentation in 1990, it failed to correct that misrepresentation despite the knowledge that  
the implants were being improperly imported and sold in Canada and that there was strong and  
growing evidence that the implants were unsafe and caused serious harm to users. These  
allegations, taken in combination, in my view, describe a relationship between Health and  
Welfare Canada and the users of those implants that is different from the relationship that exists  
between Health and Welfare Canada and consumers of medical devices at large. The more  
Page: 116  
[344] As I read the decision, this conclusion was at the centre of, if not fundamental to, the  
determination it was not “plain and obvious” that the action could not succeed.  
[345] Now, at the end of the trial, what is there that supports the proposition that the Crown  
“repeatedly misrepresented” that the implants received by the representative plaintiff “and  
others” had been issued Notices of Compliance when they had not? There is only one document  
that suggests this could have happened. On August 25, 1989, which is to say just over one year  
since the letter of July 11, 1988 advising of the grant of Notices of Compliance for “facial Block  
and Sheeting” and just less than one year since the letter of September 2, 1988 confirming that  
further more particular information was required to establish the safety and efficacy of “Proplast  
T.M. Joint Implant[s]”, Information Letter 765 was released by the Health Protection Branch. It  
was addressed to “Manufacturers and Distributors of Medical Devices.” Its stated purpose was:  
It has been the practice of the Health Protection Branch to issue, on an annual  
basis, a list of new devices for which Notices of Compliance have been issued.  
The attached document is an update of Information Letter 751 and includes those  
devices for which Notices of Compliance were issued during the period January  
1, 1988 to December 31, 1988.385  
[346] The Information Letter is accompanied by a 60 page list of devices, broken down by  
category, that had been granted Notices of Compliance over the 1988 calendar year. Included on  
page 20 under the heading “Musculoskeletal System/Systeme Musculo-Squelettique” are  
products attributed to Vitek Inc. for which it was said Notices of Compliance had been issued.  
Four on the list that appear under three headings are:  
Proplast HA:  
TMJ Fossa Prosthesis Type VK  
Proplast HA/UPE:  
TMJ Fossa Prosthesis Type VK  
Fossa Prosthesis Type VK  
Proplast HA:  
TMJ Condylar Prosthesis Type VK  
difficult question is whether the allegations create a sufficiently close relationship to give rise to  
a private law duty of care.  
I will consider the further allegations as these reasons proceed.  
385 Exhibit 12 T. 35, Exhibit 56 T. 15 (Information Letter 765)  
Page: 117  
[347] This group includes only some of the many devices for which Vitek Inc. applied for  
Notices of Compliance as “TM Joint Implants”. The Record includes a list of Vitek Inc.  
products. It is broken down into separate listings of those granted and those refused a Notice of  
Compliance.386 The list of those granted a Notice of Compliance is a copy of the Notice of  
Compliance. The list of those without Notices of Compliance includes the four identified in the  
Information Letter as having received Notices of Compliance when they did not. These four, in  
turn include:  
four devices identified as Proplast HA TMJ Fossa Prosthesis, Type VK (813.06,  
813.07, 813.08, 813.09)  
four devices identified as Proplast HA/UPE TMJ Fossa Prosthesis, Type VK  
(813.16, 813.17, 813.18, 813.19)  
four devices identified as Proplast HA TMJ Condylar Prosthesis, Type VK  
(813.61, 813.62, 813.67, 813.68)  
There is no grouping for “Proplast HA/UPE Fossa Prothesis Type VK” without  
the reference to “TMJ”.  
[348] These are the only ones that Information Letter 765 identifies, incorrectly, as having been  
issued Notices of Compliance when they were not. There are other Proplast TM Joint Implant  
devices produced by Vitek Inc. that did not receive Notices of Compliance. The Information  
Letter does not refer to them as having received Notices of Compliance. On the list (as opposed  
to the Information Letter) they, along with the four improperly identified on the Information  
Letter, are shown as not having been granted Notices of Compliance. These are:  
six listed as Proplast HA Interpositional Implants, Non-Porous Teflon Laminate  
Concave-Trapezoidal Shape w/Articular Eminence Extension,  
three listed as Proplast II Interpositional Implant, Non-Porous Teflon Laminate  
Concave-Trapezoidal Shape w/Articular Eminence Extension 2/Box,  
three listed as Proplast II Interpositional Implant, Non-Porous Teflon/ Polyaramid  
Fabric Laminate, Concave-Trapezoidal Shape w/Articular Eminence Extension,  
2/Box  
four listed as TMJ Glenoid Fossa Prosthesis, Type VK, and  
four listed as Proplast II/UPE TMJ Glenoid Fossa Prosthesis, Type VK  
[349] I go through this now to establish that any direct reliance on the Information Letter, and  
the error it contained, as establishing the connection necessary to demonstrate that a duty of care  
386 Exhibit 12 T. 32, Exhibit 56 T. 16  
Page: 118  
is owed to any particular member of the class would have to be specific to one of the four types  
of implant that were the subject of the error. I mean by this that the class member or those  
involved in treating that class member relied on the misrepresentation found in the Information  
Letter and on that basis put in an implant that had not received a Notice of Compliance. The  
only other way this limited mistake could be the foundation for a finding that the requisite duty  
of care was in place would be to translate it into a general misrepresentation that is attributable to  
all of the Vitek Proplast TM Joint Implants:  
The nature of any representations made by the regulator, and the nature of any  
reliance placed on those representations by the plaintiff, are part of the entirety of  
the circumstances to be considered in determining the directness of the  
relationship between the regulator and the plaintiff. Representations made  
specifically to a plaintiff and relied on by that plaintiff can clearly forge a direct  
connection between the regulator and the plaintiff. General representations made  
by the regulator to the public and relied on by the plaintiff as a member of the  
public do not, standing alone, create a direct relationship. However, general  
representations and reliance on those representations can, in combination with  
other factors, create a relationship between the regulator and the plaintiff that is  
sufficiently close and direct to render it fair and just to impose on the regulator, in  
the conduct of its duties, an obligation to be mindful of the plaintiff's legitimate  
interests.387  
[350] What are the circumstances here? How is it this error was made and what evidence of  
reliance by members of the class can be established? The error was traced back to a database that  
recorded the regulatory status of various and many devices for which Notices of Compliance had  
been requested:  
There was a database that contained submissions and submission tracking system,  
and basically you run a report to say between date A and B which one have  
received a status notice of compliance and run the printout, and then you reformat  
that a million time[s] because PCs were not on anybody's desk at that time.388  
[351] A printout was exhibited. The four devices noted in the Information Letter as having been  
granted Notices of Compliance are shown as “ACCEPTED”. They should not have been. The  
error was in the input to this database. How this happened was not, nor it seems can it be,  
explained. The Submissions of the Plaintiff contains the following paragraph and footnotes  
which summarize the support for this assertion389:  
Mrs. Chopra was unable to explain why four devices were shown in the database  
print out as having been approved on September 2, 1988.390 Similarly, Mr. Boulay  
had no information on why TMJ implants were shown as having been approved in  
387 Taylor v. Canada (Attorney General), supra (fn. 35) at para. 118  
388 Transcript of Louis Boulay (June 11, 2019) at p. 61  
389 Submissions of the Plaintiff at para. 371  
390 Transcript of Nirmala Chopra (April 23, 2019) at pp. 94-96  
Page: 119  
Information Letter 765.391 He testified that the source of the information in  
Information Letter 765 was the Health Canada database that “contained  
submissions and submission tracking system.392 Mr. Boulay confirmed on  
examination that no one outside the Pre-Market section had access to the  
database.393 Mr. Boulay could only speculate that “[t]here was an error in data  
entry in the internal database”.394 Mr. Boulay confirmed that Information Letter  
765, dated August 25, 1989, included a number of TMJ implants395….  
[352] Lindsay Blaney said the same thing. It was Francine Jacques (Gaudette) who told her  
there had been a coding error.396  
[353] Despite this the Submissions of the Plaintiff treat these specific temporomandibular joint  
implants as having been approved. The following specific submission is made:  
In addition, the Plaintiff submits Health Canada was negligent in granting NOCs  
to the TMJ devices that received NOCs on September 2, 1988.397  
[354] As the letter of September 2, 1988 made clear that Notices of Compliance for Proplast  
T.M. Joint Implant (Submissions numbered MSO39288 to MSO40188) were refused on that day,  
391 Transcript of Louis Boulay (June 12, 2019) at pp. 5-26  
392 Transcript of Louis Boulay (June 11, 2019) at pp. 60-61  
393 Transcript of Louis Boulay (June 12, 2019) at p. 26  
394 Ibid at pp. 6-7  
395 Ibid at pp. 5-26  
396 Transcript of Lindsay Blaney (September 18, 2019) at pp. 82 and 106:  
Q. Now, when you say there was a coding error what do you mean by that?  
A. I would never be able to explain in detail what that means. I was told that, you know when I  
found out about this, that there had been some type of entry error, coding error. And so I don’t  
know more than that.  
Q. Do you recall who told you that?  
A. I think it was Francine Jacques.  
Q. The information letter that spoke of Notice of Compliance in fact having been issued when  
we spent some time earlier this afternoon talking about Fossa, 3 Fossa and one condylar VK.  
And the Fossa and condylar implants we were speaking of earlier this afternoon. Do you recall?  
A. Yes I do.  
Q. And this was the coding error issue, those implants. Your position is they were never given a  
Notice of Compliance?  
A. They were never given a Notice of Compliance.  
397 Submissions of the Plaintiff at para. 364  
Page: 120  
not granted (see para. [268] above). How can the Plaintiff say otherwise? Lindsay Blaney was  
National Co-ordinator for the Field Operations directorate from 1990 to 1994. In that capacity  
she acted as a liason with the regional offices and program bureaus, one of which was the  
Medical Devices Bureau. From 1994 to 1998 she was a scientific evaluator for that bureau.  
Lindsay Blaney was referred to a handwritten note she had prepared on November 9, 1994.398  
Whereas she had previously testified that only facial implants had received Notices of  
Compliance, this note identified three temporomandibular joints implants as having been  
approved. These were: (1) MS039488 being Proplast HA TMJ Fossa Prosthesis Type VK, (2)  
MS039588 being Proplast HA/UPE TMJ Fossa Prosthesis Type VK and (3) MS039688 being  
Proplast HA/UPE Fossa Prosthesis Type VK. Lindsay Blaney was unable to explain how it is  
that this document showed these devices as having been approved. The answer is they were not  
approved. They are three of the four devices incorrectly recorded as having been approved in  
Information Letter 765.  
[355] The plaintiff insists these products were granted Notices of Compliance:  
There is no evidence to indicate that Health Canada did not, in fact, approve the  
four TMJ devices. The only evidence indicates that these devices were approved  
on September 2, 1988….399  
[356] This is untenable. The evidence is that on September 2, 1988 the letter was written  
explaining why implants of this type would not be granted Notices of Compliance. This was  
preceded by the letter of July 7, 1988 from W. J. Welsh to Gene L. Fagelson indicating that  
safety and efficacy data would be required if Notices of Compliance were to be issued. The fact  
is that no Notice of Compliance was ever produced. The Plaintiff’s position might have been  
sustained if her counsel could explain why the letter of September 2, 1988 is wrong and why,  
given the approval they maintain took place, there was no Notice of Compliance issued. The note  
prepared by Lindsay Blaney is wrong. It depends on the database which, for whatever reason, is  
wrong and is the source of the error. Lindsay Blaney said it was wrong although she, herself, was  
unable to say how the error came about.400 The four temporomandibular implants (and the  
groupings they represent) were not given Notices of Compliance. The better question is whether  
there was any possibility the note and its content or the database could have been released, made  
public or, in some other fashion become known such that interested health professionals or the  
patients they treat could have or did rely on the error the two documents contain. The note was  
internal to the Health Protection Branch and, as the paragraph from the Submissions of the  
Plaintiff quoted above notes, “no one outside the Pre-Market section had access to the database”.  
[357] As for the Information Letter, Louis Boulay, who had from time to time filled in for  
Nirmala Chopra and subsequently replaced her as Head, Premarket Review testified that the  
purpose of providing this information was strictly commercial. The Medical Devices Bureau  
would frequently receive telephone calls from manufacturers and distributors seeking  
398 Exhibit 71 T. 18  
399 Submissions of the Plaintiff at para. 375  
400 Transcript of Lindsay Blaney (September 20, 2019) at p. 61  
Page: 121  
information regarding which of their competitors’ devices had received Notices of Compliance.  
The Information Letter was intended to provide this information directly to the industry such that  
manufacturers and distributors would know what devices their competitors could sell and  
advertise.401 In light of this purpose, the Information Letter was distributed only to manufacturers  
and distributors of medical devices.402 It was not intended for and was not delivered to health  
professionals or patients:  
No, it was not the target. If a letter was intended for a group of doctor[s] we had  
another type instead of information it's a "dear doctor" letter, and then it  
contains some relevant clinical data that would be of interest to them. This is for  
a doctor very dry reading, so that's unless it's some clinical interest, quite often  
they would not even read that, so there's "dear doctor" letter or there's "dear  
petitioner" letter, I think there's different types of communication tools. This one  
was just information to the distribution list we have there. So there was other  
types of letters for other groups.403  
[358] It was sent to those who had a commercial interest:  
Often competitors wanted to know what the competition had on the market. We  
did get many phone calls when something showed up on the market, did they get  
approval last week or not, and then so the target was, as pointed out in the top  
of the letter, manufacturers and distributors.404  
[359] There was no evidence from any doctor, or for that matter any patient, that he or she read  
this Information Letter or relied on it to come to an understanding that the four devices it refers  
to had received Notices of Compliance and based on that reliance implanted a patient with any  
one of them. The representative plaintiff was unaware of the document’s existence as of late  
2017, nearly 30 years after its publication and 18 years after the commencement of this  
litigation.405 There was no evidence that any person in Canada was ever implanted with one of  
the Vitek Proplast TMJ implants erroneously listed in Information Letter 765, at any time, after  
its publication in August 1989.  
[360] Quite apart from the understanding that the four Vitek Proplast TMJ implants did not  
receive Notices of Compliance is the fact that, as noted in the Submissions of the Defendant, the  
Plaintiff, unlike the position now taken on her behalf, pleaded in her Second Fresh Statement of  
Claim (April 28, 2014) that no Notice of Compliance had been issued in respect of the four Vitek  
Proplast TMJ Implant noted in the Information Letter as having been granted them:  
401 Transcript of Louis Boulay (June 11, 2019) at p. 62-63  
402 Ibid at p. 63 to 68  
403 Ibid at p. 64  
404 Ibid at p. 62  
405 Exhibit 72, T. B pp. 213-214  
Page: 122  
Health Canada staff recorded in Health Canada computer [sic] that Notices of  
Compliance were issued for Vitek TMJ implants despite no such Notice of  
Compliance having been issued.  
Staff of the Clinical Assessment Division of Health Canada failed to report to the  
Field Operations Division of Health Canada that Vitek TMJ implants were being  
advertised for sale in Canada by Vitek and Instrumentarium in Canadian and  
American publications and journals directed at the medical and dental  
professions, despite the fact that these devices had not received Notices of  
Compliance, staff in the Field Operations Division of Health Canada failed to  
follow up on such reports.406  
[361] The Statement of Claim, as quoted, is the form that is current and was relied on at trial. It  
came after the decision of the Court of Appeal that determined, based on the pleading, then, in  
place, that it was not plain and obvious that the Plaintiff could not succeed; that is that it was not  
plain and obvious that Health and Welfare Canada could not be found to owe the Plaintiff a  
private law duty of care. The allegation that these devices were misrepresented by Health and  
Welfare Canada as having been granted Notices of Compliance when they had not was the  
foundation on which this action was allowed to proceed:  
The sustainability of Ms. Taylor's claim at this stage of the proceedings depends  
primarily on the allegations of Health Canada's misrepresentations as to the status  
of the Vitek implants between 1988 and 1990 and its failure to correct those  
misrepresentations in the following years during which the implants were sold  
into Canada without proper authorization and the evidence of the danger posed by  
those implants continued to mount. Those allegations can be summarized as  
follows:  
- sometime in 1988, Health Canada wrongly represented in its database that  
it had issued a notice of compliance referable to the Vitek implants;  
- at various times in 1989, Health Canada, through its officials, repeated the  
misrepresentation concerning the status of the Vitek implants and  
indicated that Vitek had filed data establishing the safety of the implants to  
Health Canada's satisfaction;  
- in 1990, Health Canada discovered that it had wrongly represented that the  
Vitek implants had received a notice of compliance, but it took no steps to  
advise users or potential users of the implants or their health care  
professionals of Health Canada's misrepresentation;  
406 Second Fresh Statement of Claim paras. 143(k) and 143(l)  
Page: 123  
- to Health Canada's knowledge, Vitek continued to sell implants in Canada  
between 1988 and 1990, without the requisite notice of compliance407  
[362] This is important. The Crown not having understood the position of the Plaintiff to be  
that, in fact, Notices of Compliance had been issued, was denied the ability to question any  
witness, particularly those it called, as to this understanding of the circumstances. As an  
example, the note written by Lindsay Blaney on November 9, 1994, the one saying that three  
Vitek Proplast implants had received Notices of Compliance, arose from a conversation she had  
with Francine Jacques (Gaudette) (see para [354] above). As such the evidence was hearsay. Had  
the Crown been aware of the reliance on this memorandum and the conversation on which it is  
founded counsel would have known to question Francine Jacques (Gaudette) about it. As it is,  
she was not asked.  
[363] I confirm the problem associated with the late adoption of this position by observing that  
in the course of the opening statements counsel for the Plaintiff was clear that the position being  
taken was that Information Letter 765 misrepresented the status of the four devices when it said  
they were approved:  
THE COURT: Oh. This is the thing [referring to Information Letter 765] that says  
it’s been approved when it really hadn’t been? Is that what this is?  
MR. LEGGE: That’s what I am saying.408  
[364] Counsel went on to propose that the negligence that would be demonstrated, as the  
evidence proceeded, was the failure to withdraw the statement that the devices in question had  
received Notices of Compliance when they had not.409 The same position was taken by counsel  
on behalf the Ontario Health Insurance Plan which was separately represented as a result of its  
subrogated interest in the return of payments it has made to members of the supposed class. It  
moved through the trial, hand in hand with the Plaintiff. There was a lengthy exchange between  
counsel and the Court in which counsel said that the representation in Information Letter 765 that  
the four devices had Notices of Compliance when they did not had been relied on to the  
detriment of members of the class.410 As already noted, as the case has developed, there was no  
evidence that this was so.  
THE INSPECTIONS  
[365] The evidence of Francine Jacques contributes to an understanding of the circumstances  
and context of the work being undertaken by those involved in the regulation of medical devices  
during and around 1985 and beyond. Francine Jacques (Gaudette) testified using her married  
name. In some of the material she is referred to as Francine Gaudette and to avoid any confusion  
is referred to in these reasons as Francine Jacques (Gaudette). Like Pierre Blais, the reliability of  
407 Taylor v. Canada (Attorney General), supra (fn. 35) at para. 109  
408 Transcript of Opening Submissions (April 1, 2019) at p. 71  
409  
Ibid at pp. 73-74,  
Ibid at pp. 75-81  
410  
Page: 124  
the evidence of Francine Jacques (Gaudette) was questioned. She was produced by the Crown.  
The concern was raised on behalf of the Plaintiff. She retired in 2008. This was after this action  
had commenced but years before the trial. She was paid for her time. The Plaintiff says this  
identifies her as an “interested witness” whose testimony should be evaluated from that  
perspective. In making this submission, counsel for the Plaintiff relied on three cases. None of  
them provide any definition of what demonstrates that a witness is interested. Presumably this  
refers to an interest in the outcome of the trial: in the damages that may result, a particular  
relationship with the individual or corporation which may receive or have to pay them or, in a  
criminal proceeding, in the finding of guilt or not. Here the idea is that a witness who returns to  
the service of her employer to work on a trial and is paid for that service should be accepted as  
“interested”. It is difficult to see why this would not apply to any witness who is paid. The  
proposition is that the bias and perspective of such a witness should be taken as purchased. This  
can happen but it has to be demonstrated by more than the presence of payment. Generally, this  
occurs when the witness is perceived by the Court as having become an advocate for a given  
position rather than as a dispassionate observer. That is not the case here.  
[366] Of the three cases referred to by the Plaintiff, two of them are criminal cases where the  
accused had been charged with sexual assault. In R. v. M. G.411 it was the credibility of the  
complainant that was at issue. As the complainant, the witness’s “interest” in the outcome is not  
hard to see. As it is, although the words “interested witness” are used in one of the quotations  
(from another case) referred to in the judgment, those words were not associated with the  
complainant. The reasons refer to her as a “crucial witness” which is the better description.  
Otherwise every witness who has a view of what took place, or was involved in some way, could  
be said to be “interested”. The second case is R. v. Kiss.412 This was the proverbial “he said, she  
said” case. Whose story was to be believed: the accused or the complainant? Again, without  
reference to the term “interested witness” in conjunction with the case itself, it seems that the  
concern, if it is to be applied, was to the complainant who was believed. The account of the  
complainant was “a central theme in this case”. The trial judge’s treatment of this evidence was a  
ground of appeal. It was rejected. He found the complainant’s story “plausible i.e., in harmony  
with the way things can and do happen”. The Court of Appeal found this “appropriate”. The  
appeal from conviction was granted because of the failure of the trial judge to examine a  
particular piece of evidence (the shirt the complainant was wearing at the time of the alleged  
assault), because of the misuse of evidence called in reply and because of the trial judge’s  
“uneven scrutiny” of the competing evidence.  
[367] The third case relied on by the Plaintiff is Faryna v. Chorny.413 The appellant wrote a  
letter questioning the chastity of the respondent. The witness to whom the letter was written left  
it where the plaintiff discovered it. The law suit was for libel. The plaintiff was successful.  
Among the questions on the appeal was the treatment of the evidence of the recipient of the  
letter. Should the judge’s “interlocutory remarks” made during the trial be taken as findings as to  
411 1994 CanLII 8733 (ON CA), 73 OAC 356, 93 CCC (3d) 347, 24 WCB (2d) 643, [1994] CarswellOnt 181,  
[1994] OJ No 2086 (QL)  
412 2018 ONCA 184 (CanLII),  
413 [1951] B.C.J. No. 152, [1952] 2 D.L.R. 354, 1951 CarswellBC 133  
Page: 125  
the reliability of that evidence and is it proper that a finding of credibility depend solely on  
which person the trial judge thinks made the better appearance of sincerity in the witness box?  
The answer to the first proposition is “no”. Such remarks are commonly made as part of the  
judge’s inquiry and not demonstrative of any determination. The answer to the second question  
is also “no”; the demeanour of the witness is not enough. This is the point that both R. v. M.G.  
and R. v. Kiss extract from Faryna v. Chorny. Each contains the following quotation, as do the  
Submissions of the Plaintiff:  
The credibility of interested witnesses, particularly in cases of conflict of  
evidence, cannot be gauged solely by the test of whether the personal demeanour  
of the particular witness carried conviction of the truth. The test must reasonably  
subject his story to an examination of its consistency with the probabilities that  
surround the currently existing conditions. In short, the real test of the truth of the  
story of a witness in such cases must be its harmony with the preponderance of  
probabilities which a practical and informed person would readily recognize as  
reasonable in that place and in those conditions.414  
[368] If this is what is said to distinguish the treatment of “interested witnesses” from others,  
time has passed it by. Faryna v. Chorny was decided in 1951. What was said in that case may  
have been new at the time; it is not today. For the most part, courts have learned that demeanour,  
taken on its own is not a reliable way of assessing the credibility of any witness. It is recognized  
that those who lie out of habit, or are pathologically inclined to do so may, through a confident  
and forthright appearance, be taken as truthful. On the other hand, those unfamiliar with the  
formality of a court room, in their anxiety to comply with the obligation to be truthful, may seem  
nervous and uncertain and, based on demeanour alone, taken to be other than credible. As is said  
in Faryna v. Chorny the circumstances, conditions, consistency or lack of it with other evidence  
should be included as part of the analysis.  
[369] The Plaintiff says there are inconsistencies in the evidence of Francine Jacques  
(Gaudette) that should (along with the fact that she was paid) lead the Court to find her evidence  
is not credible and make findings that contradict it. I reject this submission. The examples given  
suggest she has:  
recognized the continuing failure of the company to comply with the requirements  
of the Medical Devices Regulations respecting the permission to sell and  
distribute such devices, the implication being that a more forceful form of  
enforcement should have been employed;415  
understood that devices, without the requisite permissions were being directly  
imported by doctors (referred to as “private importation”) thus putting patients in  
Canada at risk;416 and  
414 Ibid at para. 11, R. v. M. G. supra (fn. 411) at para. 32 and R. v. Kiss, supra (fn. 412), at para. 30  
415 Submissions of the Plaintiff at paras. 436-441  
416 Ibid at paras. 442-443  
Page: 126  
realized that when she passed on the decision as to whether all doctors and  
dentists, in Canada, should be notified as to the concerns with Vitek Proplast  
implants to Health and Welfare Canada doctors and scientists, their decision was  
not based on scientific or health-based considerations.417  
[370] Each of these issues is taken up in what follows. The overall context infiltrates each of  
these discussions. Regardless of whether Francine Jacques (Gaudette) is an “interested witness”  
the guidance provided by Faryna v. Chorny has been adhered to. The evidence has been  
analysed, weighed and considered in the findings made. For the moment I point out that, as will  
become clear:  
in respect of the failure to impose stronger enforcement, I note that the regulatory  
scheme was new and a policy determination made that it was better to work with  
the companies involved, to educate and instruct, hopefully, to the benefit of those  
who would be assisted by devices brought properly to market;  
in regard to “private importation”, it is not certain there was any and if there was,  
the numbers are small; and  
concerning the notification of physicians and surgeons, Francine Jacques  
(Gaudette) passed these decisions on to those responsible for making them; there  
was a broader context to be considered.  
[371] I find that Francine Jacques (Gaudette) was not an “interested witness”. There is nothing  
in what she said that suggests a bias, a particular perspective on how these events should be  
understood or their legal impact determined. Being paid for her time is not enough. Uncertainties  
or supposed conflicts are not necessarily, and in this case are not, demonstrative of a witness  
being an “interested” one. The demeanour of Francine Jacques (Gaudette) was in no sense  
determinative of the weight, import or credibility given to her evidence but in the circumstances,  
I take the time to observe that she was forthright, did her best to be complete and showed as a  
committed servant to her responsibilities and understanding.  
[372] Francine Jacques (Gaudette) had a long history of employment with Health and Welfare  
Canada. She began her employment with the Québec region in 1973. At that time, she was  
trained as a food and drug inspector. She was required to have, and had, a degree in science, in  
her case in organic chemistry. With two breaks, one from 1978 until 1981 when she was rehired  
and another from 1983 to 1985 when she returned from a maternity leave, she was employed by  
Health and Welfare Canada until her retirement. In 1985, upon her return from maternity leave  
she joined the medical devices unit. This was an important moment in the evolution of the  
approach taken in the regulation of medical devices. It was shortly after the effective date of the  
amendments to the regulation promulgated in 1983. As described by Francine Jacques  
(Gaudette) the activities of the inspectors were becoming more proactive. They were initiating  
interaction with corporations active in the industry. It was a period of education of those  
417 Ibid at paras. 444-445  
Page: 127  
companies and rationalization of their operations in the context of the changed regulatory  
scheme. When she joined the medical devices unit, in the spring of 1985, she, along with others  
involved, as part of their education as to those changes, met with people associated with the  
Environmental Health Directorate who were engaged in research and the evaluation of medical  
devices. They met with workers at the Radiological Health Centre to learn what those workers  
were doing and to establish relationships so that the help of those workers would be available, if  
required. In November 1985 she organized a seminar to inform the industry and stakeholders  
about the regulation of medical devices; 2000 people attended.418  
[373] As part of this process of education and rationalization, for the first time, a project  
entitled “Inspection of Manufacturers, Importers, and Distributors of Medical Devices”, was  
undertaken in which inspectors were sent to visit industry participants. The purpose was to assist  
those companies in understanding the regulatory scheme, inspect their premises and evaluate  
their processes with the purpose of encouraging voluntary compliance with the regulatory  
scheme:  
This project will provide for a nationwide opportunity to meet industry, to gather  
information and data on several aspects of manufacturing and to determine the  
need for enforcement action.  
[374] The purpose was:  
To contact and provide Canadian device manufacturers/importers/distributors  
with the Health Protection Branch view of the current regulations, compliance  
assistance and interpretation of the regulatory requirements relevant to their  
industry.  
To obtain information about manufacturing procedures, quality control methods  
and distribution channels.  
To assess Canadian Manufacturers/importers/distributors compliance with the  
Medical Devices Regulations and to encourage voluntary compliance for  
disclosed violations.419  
[375] In furtherance of this approach, Francine Jacques (Gaudette), on March 18, 1986, visited  
Instrumentarium Inc. in Terrebonne, Québec. In preparation for the visit she reviewed the  
regional file to learn about any previous visits that had taken place, any problems that had  
appeared and whether the company had been cooperative. Had it taken action as requested?420  
418 Transcript of Francine Jacques (June 17, 2019) at p. 5  
419 Exhibit 59 at T. 11 (Device Manufacturing Practice Evaluation (March 1984) and Exhibit 61A T. 71 as well as  
Agreed Statement of Facts at para. 88 itself footnoting AGC-08407. 004 apparently retitled as: Inspection of  
Manufacturers, Importers and Distributors of Medical Devices (January 4, 1986)  
420 Transcript of Francine Jacques (June 17, 2019) at p. 20  
Page: 128  
[376] On December 20, 1985, that is prior to the inspection, the Québec Region of Health and  
Welfare Canada’s Field Operations Directorate (“FOD”) provided the Secretary-Treasurer of  
Instrumentarium Inc. with copies of the 1978 codification of the Medical Devices Regulations  
and extracts from the Food and Drugs Act applicable to medical devices, a guide on device  
labelling, a brochure on medical instruments, a copy of Information Letters dealing with new  
devices and clinical trials, and a guide on preparing submissions under Part V of the Medical  
Devices Regulations.421 This was an initial step in the effort to educate this member of the  
medical devices industry.  
[377] The inspection of March 18, 1986 was conducted in the context of the “project” the stated  
purposes of which are quoted above. During the course of the visit, Francine Jacques (Gaudette)  
filled out a reporting form422; it was subsequently typed.423 There was a second page or version  
of this form,424 also later converted to type.425 The report includes an appendix 3: “Investigative  
Report”.426 It too was later typed.427 The report was followed by a letter, dated April 1, 1986,  
from Francine Jacques (Gaudette) to Michelle Laferrierre Lemieux, Secretary-Treasurer of the  
company.428 Under the heading “General Remarks” the report notes, among other things:  
In operation since 1977, this firm has never issued a device notification. More  
than 70 manufacturers are supplying it with products and approximately 20 of  
them have completed declarations naming the firm as a distributor for more than  
3000 products.  
Ms. Lemieux [the Secretary-Treasurer] did not appear to be very well-informed  
about our legislation. Her initial contact with us was not until December 1985.429  
[378] The appendix underscores the concern with the company’s failure to properly provide  
notification of devices it intended to market:  
Device notification  
The firm has not completed any declaration since its beginning in 1977. However,  
24 of its 71 suppliers have, and they have named the firm as a distributor.  
421 Agreed Statement of Facts at para. 87 itself footnoting the letter enclosing the listed material. The Agreed  
Statement of Facts shows the letter as having been dated December 10, 1985. The letter, itself, is dated December 20  
1985. I have used the date from the letter.  
422 Exhibit 59 at T. 4  
423 Ibid at T. 16  
424 Ibid at T. 72  
425 Ibid at T. 16 and 72  
426 Ibid at T. 4  
427 Ibid at T. 72  
428 Ibid at T. 17  
429 Ibid at T. 16 (On what I have referred to above as the second page or version)  
Page: 129  
[379] The appendix goes further. It expresses a concern in respect of those products to which  
Part V applied; that is those requiring a Notice of Compliance:  
New devices/notice of compliance  
The firm has been selling a few implants for a number of years, including Proplast  
prosthetic devices (Vitec) [sic] and Allen ophthalmic implants (Precision-  
Cormet). Since April 1983, only one implant has been marketed, namely Cotrel  
rods (1984). Instrumentarium has sent French manufacturer Sofamor all the  
documentation on applying for a notice of compliance for the project. There were  
no Cotrel rods in stock.  
[380] The report, in company with the appendix, outlines three concerns derived from the  
inspection:  
The Secretary-Treasurer of the company did not have a proper understanding of  
the regulatory regime. This was partly explained by the death of her husband who,  
it seems, had been the directing mind of the company. Michelle Laferrierre  
Lemieux had only recently taken over. She had been a nurse.430  
The difficulty with the notification of the products being sold was explained by  
Francine Jacques (Gaudette). The notification requirement applied to  
manufacturers. As noted in the quotation above, from the appendix, of the 71  
suppliers to Instrumentarium Inc. 24 had complied with this requirement.  
There were Proplast implants on site. They had been sold through Intrumentarium  
Inc. since the 1970’s. There is nothing to suggest those seen, during her  
inspection, by Francine Jacques (Gaudette), were temporomandibular joint  
implants. To the contrary her recollection was of “a dimple chin implant”431  
which would be cosmetic and not orthopaedic. Of greater concern were the  
“Cotrel rods” which Instrumentarium Inc. offered for sale. These are the implants  
used to treat teenagers with curvature of the spine.432 There were none in stock433  
but they had been the subject of a telephone call from Michelle Laferrierre  
Lemieux to Health and Welfare Canada inquiring as to the applicable regulations  
governing their sale.434 They were subject to the requirements of Part V of the  
Medical Devices Regulations. They had to have a Notice of Compliance.435  
[381] The letter of April 1, 1986, that followed up on the inspection dealt with the issues of  
concern, in particular “Device notification” and “New device[s]”:  
430 Transcript of Francine Jacques (June 17, 2019) at p. 37  
431 Ibid at p. 52  
432 Ibid at p. 80  
433 Ibid at p. 68 and p. 79  
434 Ibid at pp. 38-39  
435 Ibid at p. 39 and p. 79  
Page: 130  
Device notification  
A notification has not been provided for every device you are selling, as  
required under section 24 of the Medical Devices Regulations, within 10 days  
from the day of which each device was first sold.  
[382] The letter does not stop there; it provides further information and instruction as to how  
the company should proceed:  
Enclosed is a computer printout of the suppliers that have fulfilled this  
requirement and named you as a distributor:  
As for your other suppliers, you must contact them as soon as possible and ask  
them either to authorize you to complete the declaration or to complete the  
declarations themselves.  
[383] The letter goes further. It offers the assistance in complying with the regulations:  
Gilles Latulippe, who heads the declarations section of the Bureau of Medical  
Devices, Ottawa, [telephone number provided], would be pleased to assist you  
should you encounter any problems in complying with the regulations.  
[384] It appears that Michelle Laferrierre Lemieux (referred to as Michelle Laferrierre) took up  
the offer. Gilles Latulippe wrote to her, on April 21, 1986, in response to a letter he had received  
from her dated April 15, 1986.436 On May 1, 1986, Gilles Latulippe wrote to Vitek Inc. to inform  
that Health and Welfare Canada had reason to believe that Vitek Inc. was advertising medical  
devices in Canada. Gilles Latulippe went on to advise Vitek Inc. of the notification requirements  
prescribed by the Medical Devices Regulation. He sent a copy to Michelle Laferrierre  
Lemieux.437 Gilles Latulippe went further. He undertook to contact each of the suppliers of  
Instrumentarium Inc. to ask them to either complete the notification form or to authorize  
Instrumentarium Inc. to do this on their own behalf.438  
[385] In respect of “New device[s]” the letter of April 1, 1986 states:  
New device  
Section 33 of the Regulations prohibits the sale of a new device without a notice  
of compliance. The sale of Cotrel Rod implants is therefore not permitted until the  
manufacturer obtains a notice of compliance for it (section 34). Needless to say,  
this applies to any implant from a given manufacturer marketed in Canada as of  
April 1983.  
436 Exhibit 61A T. 15 and Exhibit 59 T. 20  
437 Agreed Statement of Facts at para. 90; Exhibit 59 T. 21  
438 Transcript of Francine Jacques (June 17, 2019) at p. 107; Exhibit 59 (Medical Device Plant Inspection Report,  
Appendix 3)  
Page: 131  
[386] Francine Jacques (Gaudette) explained that Intrumentarium Inc., was not unique. It was a  
common occurrence that distributors were selling medical devices in circumstances where the  
manufacturer had not provided the required notification. The responsibility to give notice lay  
with the manufacturer not the Canadian distributors unless they had written authority from the  
manufacturer. The vast majority of devices (95%) sold by Canadian distributors were  
manufactured outside of Canada, and it was difficult for Canadian distributors to comply with  
the notification requirement since they would need the cooperation of the foreign  
manufacturer.439  
[387] At a time shortly after her visit to Instumentarium Inc., as a result of looking at custom  
manifests, Francine Jacques (Gaudette) became aware that the company was receiving Cotrel  
rods. Francine Jacques (Gaudette) wished to ensure that the product was not being sold. She  
sought advice as to whether or not a Notice of Compliance had been issued. It had not. As part of  
her inquiry, Francine Jacques (Gaudette) called Pierre Blais. She wanted to know more about  
Cotrel rods. What were they used for? Did he know anything about that? On June 3, 1986, she  
returned to Instrumentarium Inc. Francine Jacques (Gaudette) found that there were 81 Cotrel  
rods in stock. She advised Instrumentarium Inc. that the sale of the product would constitute a  
violation of the Medical Devices Regulations. Despite considerable pressure from surgeons, the  
company respected the regulatory scheme and did not sell the Cotrel rods.440 Francine Jacques  
(Gaudette) testified that a submission was made requesting a Notice of Compliance for the Cotrel  
rods. There were surgeons who wanted them to be available to assist their patients. At first the  
submission was rejected. The information provided was insufficient, some was missing. Francine  
Jacques (Gaudette) was directed to place Intrumentarium Inc.’s stock of Cotrel rods under  
voluntary detention.441 The problem was overcome and a Notice of Compliance was issued  
during November 1986.442 At that point, Intrumentarium Inc. was free to sell Cotrel rods.443  
[388] In the final Submissions of the Plaintiff counsel finds fault with Health and Welfare  
Canada in that on discovering Instrumentarium Inc. was selling Cotrel rods without notification  
or a Notice of Compliance, no “prompt review of the company’s stock for additional non-  
compliant devices pursuant to the regulatory powers available to Ms. Jacques and her  
colleagues” was undertaken.444 To counsel: “It is unclear why such regulatory actions provided  
for by statute did not take place against Instrumentarium after her 1986 inspection.”445  
[Emphasis added] I find the use of the word “against” instructive. This is not a circumstance  
where the regulator stands in opposition to the manufacturer. Here, there was the introduction of  
a significant change to the regulatory scheme. Health and Welfare Canada chose to follow the  
general instruction and policy directed to helping companies understand their responsibilities and  
guide them to compliance. There is nothing inherently wrong with this. With assistance, a Notice  
of Compliance was forthcoming, and surgeons were able to use Cotrel rods to the betterment of  
439 Ibid at pp. 61-65  
440 Ibid at pp. 81-87 and Exhibit 59 at T. 22 and T. 23  
441 Ibid at p. 88  
442 Ibid at pp. 87-89  
443 Exhibit 59, T. 35  
444 Submissions of the Plaintiff at para. 309  
445 Ibid at para. 307  
Page: 132  
their patients. This is consistent with the collaborative approach referred to by Janice Hopkins  
and approved as policy.  
[389] The inspection did reveal that Proplast products, albeit chin and not temporomandibular  
joint implants, were “in stock” at Instrumentarium Inc. There was follow up through the letter of  
April 1, 1986, which provided instruction on how to proceed and offered assistance through  
Gilles Latulippe who wrote directly to Vitek Inc. to advise of the concern and the regulatory  
requirements.446  
[390] Over the next three years Francine Jacques (Gaudette) continued to interact with  
Instrumentarium Inc. She summarized those activities:  
I don’t recall meeting there, but there were phone calls - phone enquiries,  
because at times I would look at custom manifests that would come in, and if I  
would see something that I don't know, is this a Part V or not, I would call them  
to ask, what is this used for, how long does it stay in the body. I would call —  
sometimes I did call Dr. Blais on one occasion, asking him, do you know what  
is the usage of that, was trying to ascertain that products coming in, could there be  
new implants if they are coming in. I was, like, overlooking, like that. I had  
contact with the company, phone calls, but there was no complaint that we had  
received, no investigation on-site, no that I am aware of in the three-year  
period before I go back in 1989.447  
[391] There was a second occasion when Francine Jacques (Gaudette) visited and inspected the  
premises at Instumentarium Inc. This happened in 1989. The inspection program pursuant to  
which the 1986 inspection had taken place continued. Each year the description was redrafted.  
The 1988 version, still entitled “Inspection of Manufacturers, Importers, and Distributors of  
Medical Devices”, remained in effect at the time Francine Jacques (Gaudette) visited  
Instrumentarium Inc. during April 1989. The three statements of purpose quoted above (see:  
para. [374 ] above), now called “Goals” remain essentially unchanged. A new “Goal” was  
included:  
To encourage the Canadian industry to use good manufacturing practices (GMP)  
and use the FDA approach as recognized guidelines in this area.  
[392] By 1989 the inspectors were better equipped and more experienced in carrying out these  
inspections:  
There is more information on how to do the inspection. We were now linked  
electronically with the Bureau of Medical Device. We had access to notification,  
446 Exhibit 59 T. 21  
447 Transcript of Francine Jacques (June 17, 2019) at p. 90  
Page: 133  
to the problem reports. We were better equipped. We were equipped with  
computers, and we were better equipped. 448  
[393] Francine Jacques (Gaudette) advised the Court that it had been established that there  
should be a follow up visit “at three years afterwards”. 449 The April 1989 inspection, following  
up on the March, 1986 visit was consistent with that direction.  
[394] As in 1986, Francine Jacques (Gaudette) prepared for the inspection that took place in  
April 1989. She looked at what she had done before. The experience with Cotrel rods had alerted  
her to concerns about Intrumentarium Inc.’s understanding of how Part V “New devices” were to  
be dealt with. She knew Instrumentarium Inc. was selling Vitek Inc. products that had been the  
subject of submissions directed to obtaining Notices of Compliance. She obtained a printout with  
all the Notices of Compliance issued and the submission numbers of those that were rejected and  
those for which more information had been required.450 There were 100 files for Vitek Inc.  
products.451 Through the review of customs manifests she recognized that there were Vitek Inc.  
devices coming through that she was not familiar with.452  
[395] Francine Jacques (Gaudette) also looked at the state of notifications sought by suppliers  
with respect to products being distributed by Instrumentarium Inc.:  
And this is where I've seen that there were now more suppliers that have filed  
notification, because in the that's what I was trying to explain, that there were  
many suppliers that had indicated that Instrumentarium was distributing their  
numerous products. There were more than 6,000 products notified from  
something like 38 suppliers….453  
[396] Francine Jacques (Gaudette) prepared a report of her inspection of April 4, 1989. In  
respect of those devices requiring only notification, in the course of giving evidence, she said  
(this is the continuation of the quotation immediately above):  
but still, when I went to the company, they were still making business with  
71 suppliers, 70, 71. I would like to see the figures. And it was still still not  
in compliance, not in total compliance. There were improvement[s] in the three  
years, but they were still uncompliant with notification.454  
[397] In the report she noted:  
Device notifications  
448 Ibid at p. 91  
449 Ibid at p. 96  
450 Ibid at p. 94 and 97-98 and Exhibit 12 T. 19 also at Exhibit 59 T. 39  
451 Ibid at p. 97  
452 Ibid at p. 98 and 101  
453 Ibid at at p. 102 and p. 104-105 where relying on her handwritten notes made at the time of her 1989 inspection  
Francine Jacques testified that there were 6,800 products for which notification had been received (Exhibit 59 T. 8).  
454 Ibid at (June 17, 2019) at p. 98  
Page: 134  
Device notifications are out of date. Only 20 of 70 suppliers have declared their  
products. Following the inspection in 1986, Instrumentarium contacted Gilles  
Latulippe. He agreed to contact all of Instrumentarium’s suppliers. The firm has  
taken no other action since then.455  
[398] Consistent with the understanding that “…voluntary compliance for disclosed violations  
is the preferred route.”456 The report goes on to suggest how this deficiency should be dealt with:  
I suggested first contacting all suppliers not in compliance with section 24 to  
obtain their authorization to produce declarations and then, once the  
authorizations have been obtained, sending them to Gilles Latulippe with a  
computer listing of the most commonly sold products (6,000 at the time of our  
visit).  
[399] Ultimately the question of how to deal with any deficiency of the notification  
requirements (by further encouragement or enforcement action) is a matter of discretion left to  
the inspector and those responsible for overseeing compliance with the regulation:  
General  
Though voluntary compliance is preferred, the procedure described below should  
be followed in the case of uncovering violations. Where follow-up of violation  
indicates that encouraged voluntary compliance did not occur, the available  
455 Exhibit 59 at T. 40  
456 Ibid at T. 38 The full statement of the paragraph in which the quotation appears states (para. 3.4):  
Though voluntary compliance for disclosed violations is the preferred route, inspector will  
initiate enforcement action where indicated and called for in the Procedure to this project under  
item 5.5 entitled Compliance/Enforcement activities.  
Paragraph 5.5 referred to states:  
Exit Interview  
During the exit interview, the inspector will draw management’s attention to violations. He will  
also confirm these violations in writing and ensure that appropriate follow-up is initiated. Refer  
to section 5.6 for information.  
That section (5.6) states:  
Compliance/Enforcement Activities  
The inspector will assess compliance with sections of the regulations outlined in 3.4.  
In all cases his assessment is based on the evaluation of a manageable sample of devices selected  
among the highest risk type ones which are offered for sale by that company.  
Page: 135  
information should be reviewed jointly with the responsible officer in the  
Operation and Compliance Division (J. Moore). Factors including the nature of  
the enforcement action to be initiated are, for example:  
- regulatory requirement(s),  
- resources available to initiate enforcement action,  
- nature of the health risk vs technical violation,  
- population at risk,  
- magnitude of public and professional concerns,  
- user qualifications,  
- potential effectiveness of regulatory action.457  
[400] It was open to the Health Protection Branch to opt for the continued encouragement of  
voluntary compliance and stands as an appropriate, reasonable and responsible exercise of that  
discretion. The collaborative approach continued. Although not fully compliant, there had been  
improvements. After her second inspection, as with the first, on April 12, 1989, Francine Jacques  
(Gaudette) wrote a letter to Michele Laferriere Lemieux (now recognized as the President of  
Instrumentarium Inc.) following up on what she had found. In line with her report and the  
continuing effort to push Instrumentarium Inc. to comply with the regulation she wrote:  
Section 24-Device notification  
A notification has not been provided for every device that you are selling. Only  
approximately 20 of your 70 or so suppliers appear in our databank.  
Some suppliers in the databank are no longer doing business with you, and others  
have never done business with you.  
Given your specific situation and the large number of products you are importing,  
we recommended a way for you to comply with this requirement. Section 26  
describes the way in which a manufacturer outside Canada may authorize an  
importer to complete device notifications.  
The section in charge of device notifications at the Bureau of Radiation and  
Medical Devices processes data regarding declarations. The section is led by  
Gilles Latulippe…  
[phone number and address provided]  
457 Ibid at T. 38 (Inspection of the Manufacturers, Importers and Distributors of Medical Devices) at para. 5.6.1  
Page: 136  
Please inform us about the action you are taking to comply with this regulation.458  
[401] In any case, for the purposes of this decision, the treatment of “Device notification” does  
not matter. It was accepted and understood by all parties that the products of concern are all  
subject to Part V of the Medical Devices Regulations. As such they required Notices of  
Compliance, notification was not enough.  
[402] The report prepared by Francine Jacques (Gaudette) following her second inspection  
(April 1989) also considered the state of Instrumentarium Inc.’s compliance with Part V. The  
report states:  
458 Ibid at T. 41  
Page: 137  
Test before sale  
The firm is selling either very simple surgical devices or Part Vs that have  
device notifications.  
[403] Where the report form requires it, Francine Jacques (Gaudette) graded this aspect of  
regulatory compliance (“Regulations concerning… (g) New device”) as an “A” which is said to  
be “Generally satisfactory”. An “A” rating is also described as meaning:  
…that no or only minor concerns are noted.459  
[404] Francine Jacques (Gaudette) indicated that she was unaware that any Part V devices were  
being sold without Notices of Compliance having been issued. She explained her understanding:  
What happened is that I thought that that company, knowing our regulation,  
having been providing submission, trying to comply with our regulation, Madame  
Lemieux, having been cooperative in the case of the Cotrel rods, telling me  
readily that this product was a Part V without the notice of compliance, I had no  
idea that she would be selling knowingly a product without a notice of  
compliance, and that printout from the Bureau of Medical Device was approved  
[sic] for me that the company Vitek was getting was complying with the  
regulations and submitting the right information, so I gave them an A rating for  
Part V products.460  
[Emphasis added]  
[405] She had the printout that showed as approved those implants that had not been.461 She  
thought that they had been approved and governed herself on that understanding. The printout  
was not a public document; it was internal to Health and Welfare Canada. As it is, Francine  
Jacques (Gaudette) understood these temporomandibular joint implants to have been the subject  
of Notices of Compliance. When she saw that they were being imported into Canada she  
accepted this as a demonstration that Instrumentarium Inc., following its experience with Cotrel  
rods, understood, accepted and had acted on its responsibility to obtain Notices of Compliance  
for these devices.  
[406] The Submissions of the Plaintiff draw attention to the importation of Proplast products  
into Canada. The proposition appears to be that since Francine Jacques (Gaudette) had available  
to her and reviewed medical device customs manifests for Instrumentarium Inc. and was aware  
that the company was importing medical devices manufactured by Vitek Inc. she should have  
stopped the importation of Vitek Proplast implants subsequently implanted into members of the  
class:  
459 Ibid at T. 38 at para. 5.7  
460 Transcript of Francine Jacques (June 17, 2019) at p. 115 I believe the word “approved” beginning the last full  
line of this quotation should be “proof”.  
461 Exhibit 12 T. 19 also at Exhibit 59 T. 39  
Page: 138  
It is unclear how a proper review by Ms. Jacques in 1986 would not have  
disclosed the multiple non-compliant importations of Vitek Proplast TMJ  
implants inserted into members of the class including Judy Munro who testified at  
trial.462  
[407] This comment is directed to the 1986 inspection. I do not accept the proposition that  
underlies this submission. The review undertaken by Francine Jacques (Gaudette) in 1986 was  
not improper. It was consistent with the program purpose of encouraging voluntary compliance  
with the regulatory scheme. It accounted for those devices requiring that notice be provided by  
the manufacturer, pursuant to what was then Part II (s. 24) of the, then current, Medical Devices  
Regulations, allowing for sale in Canada.463 It accounted for “new devices”, those requiring  
submissions and the issuance of a Notice of Compliance including those provided by Vitek Inc.  
with follow-up instructions on how to proceed, and direct communication by Gilles Latulippe  
with Vitek Inc. as the manufacturer and with each of the other suppliers of Instrumentarium Inc.  
[408] During the 1989 inspection, Francine Jacques (Gaudette) proceeded on a false  
understanding. She thought that the temporomandibular joint implants listed as accepted on the  
printout had received Notices of Compliance. Given they had not, the unanswered question is,  
had she been properly informed would she, or rather would a reasonable person with the  
appropriate knowledge and experience have recognized that those “new devices” were being  
imported without the requisite Notices of Compliance and, if so was there an obligation to act  
and was the failure to do so a breach of any duty of care that was present? I shall return to this  
later in these reasons.  
[409] For the moment I note the following. The Medical Devices Regulations referred to the  
importing of medical devices into Canada. The sections involved reflect on all medical devices  
not just “new devices”, being the ones that require a Notice of Compliance. This part of the  
regulation begins with a general prohibition:  
16. Subject to section 20 [which has no relevance to this case], no person shall  
import into Canada for sale a device the sale of which in Canada would constitute  
a violation of the Act or these Regulations.  
[410] This is followed by three sections which outline the related authority of an inspector:  
17. An inspector may examine and take samples of any device sought to be  
imported into Canada.  
18. Where an inspector examines or takes a sample of a device pursuant to section  
17, he may submit the device or sample to an analyst for analysis or examination.  
19. Where an inspector, upon examination of a device or sample thereof or on  
receipt of a report of an analyst of a result of an analysis or examination of the  
462 Submissions of the Plaintiff at para. 312  
463 Medical Devices Regulations s. 24(1):  
Page: 139  
device or sample, is of the opinion that the sale of the device in Canada would  
constitute a violation of the Act or these Regulations, the inspector shall so notify  
in writing the collector of customs concerned and the importer.  
[411] These sections have no value here. The concern is that the inspector (Francine Jacques  
(Gaudette)) thought the devices in question had received Notices of Compliance. There was no  
reason for her to take a sample or have an analyst look at one. These sections do not help  
determine how the reasonable inspector would necessarily have responded, knowing the devices  
had not received Notices of Compliance. There is discretion as to whether any device should be  
stopped and analysed.  
[412] Reference was made to a document entitled “Drug & Environmental Health Inspection  
Division, Ontario, Region: Customs Surveillance Program.464 The goals of the “Customs  
Surveillance Program” are cited as:  
1. Increase our visibility and emphasize our interest in the importation of foods, drugs and  
devices to Customs Canada.  
2. Encourage the provision of customs invoices of Customs Canada to HPB.  
3. Monitor incoming customs invoices to identify firms who have not notified on drugs and  
devices.  
4. Encourage Appraisers to hold shipments for our examination if 4th copy of entry  
document not available and to provide prompt response to requests for examination.  
5. Improve our capability to refuse entry of violative commodities at the port of entry.  
[413] These goals are directed to demonstrating interest, obtaining information and improving  
the capability to refuse entry. It is not directed to ensuring that drugs and devices will always be  
stopped or refused entry or to undertaking any legal responsibility when they are not held up at  
the border. This is underscored by the outlined “Methods of Implementation”:  
A.  
A visitation program to the Ports of entry in the Toronto area on an 8-  
week cycle. Frequency will be reassessed after implementation.  
Through implementation we will:  
1) Educate Customs Canada Staff to HPB needs  
- providing awareness of what constitutes a Drug or Device  
(Medical or Radiation Emitting Device).  
464 Exhibit 32 (Customs Surveillance Program)  
Page: 140  
- providing guidance on when a shipment should be detained for  
HPB inspection.  
2)  
3)  
Selectively examine or sample shipments being appraised (or  
recently appraised) for review of label or other compliance issues.  
Gain an appreciation of the difficulties encountered by various  
ports of entry in fulfilling their obligations.  
B.  
Monitor incoming customs invoices covering devices (Medical &  
Radiation Emitting Devices) and drugs to determine if notification  
requirements have been met.  
[414] There is no undertaking or commitment, within the program, to find and prohibit from  
entry any device not subject to notification or a Notice of Compliance.  
THE RECALL  
[415] It is not that no effort was made to advise those involved and affected by the implantation  
of Vitek Proplast implants. In 1990 there was a recall of interpositional implants (“IPI’s”). In  
1994 it became apparent that the concern for the safety of these products had extended to cover  
not only interpositional implants but also TMJ Fossa Prosthesis, Type VK and TMJ Condylar  
Prosthesis, Type VK such that practitioners were advised to follow up with patients that had been  
implanted with these devices.  
[416] It bears repeating that none of these products had received a Notice of Compliance and  
that any sales that had taken place were illegal in that the requisite acceptance by Health and  
Welfare Canada was not in place. However, as observed by Francine Jacques (Gaudette) during  
her inspections, a small number of interpositional Vitek implants had been sold through  
Instrumentarium Inc., the only Canadian distributor.  
[417] In Canada a recall of any medical device was defined and referred to in the Medical  
Devices Regulations as they appeared and applied during the material time (1990-1991):  
“recall” or “correction”, in respect of a device that has been sold, means any  
action taken in respect of the device by that manufacturer or importer thereof after  
becoming aware that the device:  
(a) is or may be hazardous to health,  
(b) fails or may fail to conform with any claims made by the manufacturer or  
importer relating to the effectiveness, benefits, performance characteristics  
or safety of the device, or  
(c) does not comply with the Act or these Regulations,  
Page: 141  
to recall or correct the device or to notify the owner or user of the device of the  
effectiveness thereof 465  
[418] What is clear is that the primary responsibility for a recall lay with the manufacturer or  
importer, in this case Instrumentarium Inc.466 The role of Health and Welfare Canada was to  
monitor the effectiveness of the firm’s recall actions. It did this through the Field Operations  
Directorate which provided scientific, technical and operational advice.467  
[419] The immediate catalyst for the recall that took place in 1990 was a “Voluntary Safety  
Alert” issued by Vitek Inc. on March 23, 1990. The Vitek Voluntary Safety Alert was addressed  
to “Dear Doctor” and among other things noted:  
The purpose of this letter is to inform you of the following reported concerns  
which affected the Vitek TMJ IPI. The corresponding catalogue numbers are  
912.71, 912.72, 912.74, 912.76, 912.77 and 912.78.  
Debris in the joint from alloplastic implants can contribute to progressive bone  
degenerative changes and to giant cell reaction. All patients including  
asymptomatic patients, should be monitored closely to assure proper patient  
maintenance. This monitoring should include clinical and radioactive  
examination.  
465 Consolidated Regulations of Canada (1978) Volume VIII, Ch 871, s. 2  
466 This is further confirmed by Part IV of the Regulations: "Recall or Correction of a Device". The applicable  
sections each begin as follows:  
s. 29 Every manufacturer and importer of a device that has been sold in Canada shall maintain  
records of the following: …  
[List of the required records]  
s. 30 Every manufacturer and importer of a device that has been sold in Canada shall, on or  
before initiating a recall or correction of the device, provides a director with the following  
information:…  
[List of the required Information]  
s. 31 Every manufacturer and every importer of a device that has been sold in Canada and in  
respect of which a recall or correction has been initiated shall notify the Director of the results of  
the recall or correction as soon as those results become known to the manufacturer or importer.  
467 Exhibit 60 at T. 1 (Information Letter 661)  
Page: 142  
… it is strongly recommended that these patients be followed indefinitely. Please  
inform all your patients who have received a Vitek IPI of the importance of  
follow-up.  
The prophylactic removal of Vitek’s IPI is not recommended.  
Additionally, do not implant any more of these devices if you have any of them in  
your possession. These implants should be returned for credit.468  
[420] Health and Welfare Canada was aware of this “firm-initiated recall…by May 16,  
1990”469. On May 17, 1990, Health and Welfare Canada sent an Information on Potential Recall  
to the Medical Device Unit in the Central Region, detailing that “IPI’s may fragment, delaminate  
or otherwise be damaged or punctured. Debris in joint from implants can contribute to  
progressive bone degenerative change and giant cell reaction.”470 By August 3, 1990, Health and  
Welfare Canada learned that four doctors in Canada had received implants.471 On August 14,  
1990, a list of Vitek Inc. products with and without Notices of Compliance was delivered to the  
Operations Division by the Premarket Review Section.472 On August 20, 1990, Instrumentarium  
Inc. issued a Product Recall, sending the Voluntary Safety Alert letter requesting immediate  
recall of all lots of catalogue no’s: 912.71, 912.72, 912.74, 912.76, 912.77, and 912.78 (the  
Interpositional Implants). The Product Recall was addressed to “All Instrumentarium Agents”  
(there were five of them) and provided these instructions:  
Please read the letter carefully and make sure that every physician having used  
these items are made aware of the situation. Also included you will find a list of  
your hospitals who have purchased any of these items, the quantity purchased and  
468 Exhibit 70 at T. 2 and Exhibit 58 T. 3  
469 Agreed Statement of Facts at para. 113  
470 Ibid at para. 114  
471 Ibid at para. 115 and see Exhibit 49 T. 11. The document states:  
According to a FDA listing of distributors and oral surgeons received from Operations and  
Compliance Division, the distributor for Vitek products in Canada is Instrumentarium,  
Terrebonne, Quebec. Only four of the listed oral surgeons on the list in Manitoba were able to be  
contacted. None of them had heard of the recall or had received the letter. Three of the doctors  
had not implanted any of the devices and the other had implanted two of them. He indicated that  
no problems had occurred with the device. He had obtained the implants from Instrumentarium.  
Nonetheless, paragraph 115 of the Agreed Statement of Facts says that by August 3, 1990 Health and Welfare  
Canada had learned that four doctors in Canada had received implants. This is as agreed to by the parties. What I  
take from this is that upon investigation not many doctors in Canada had purchased and implanted Vitek TMJ Inter-  
Positional implants. As part of the recall, it was determined that, as of August 28, 1990, Instrumentarium Inc. had  
imported 207 Vitek IPI Implants of which it retained 8, leaving 199 that had been sold, 37 of which were recovered  
as part of the recall indicating that possibly 162 had been implanted (see: Exhibit 70 T. 3 and Exhibit 59 T. 52 and  
for the English Translation also see: Exhibit 59 T. 52)  
472 Exhibit 56 T. 16  
Page: 143  
the period of the purchase. We suggest that you leave a copy of the notification  
letter behind with each of the physicians involved.  
[421] Instrumentarium Inc. asked that products be returned within 48 hours.473  
[422] Enclosed with the instruction was a list of the doctors and hospitals that had purchased  
the implants that were of concern at the time, the number purchased by each of the recipients and  
the date of those purchases. The instruction was that each and every one of the purchasers of the  
Vitek Interpositional Implants was to be contacted. There is an inconsistency that was not  
accounted for. The list that accompanies the instruction refers to 183 implants. Francine Jacques  
(Gaudette), during the course of her inspections, found that 199 had been sold.474 As it is, more  
effort than these instructions suggest was made to notify those who had purchased, implanted or  
been the recipient of one these implants.  
[423] On August 21, 1990, further to the recall, Francine Jacques (Gaudette) visited  
Instrumentarium Inc. On her arrival Francine Jacques (Gaudette) was advised that the company  
had already instructed their representatives to visit each customer and take any product left and  
to inform the physicians of the follow-up that was to be undertaken.475 Francine Jacques  
(Gaudette) did not limit the scope of her visit to Vitek Proplast-Teflon IPI’s. These were the  
devices that had been the subject of the recall. She examined all Vitek products on site. She  
detained all non-compliant devices, including eight Vitek Proplast-Teflon IPI’s:  
…That listing was very important for me because it was decided that I would  
evaluate all Vitek products on-site at Instrumentarium. And that enabled me to  
know precisely which one had a notice of compliance that had been agreed to, or  
if there were products without a notice of compliance, I detained the products. So,  
I didn’t ….Not only did I make a recall monitoring of the situation for the TMJ  
IPI, but I also look[ed] at all of their inventory of Vitek products to verify if they  
were in compliance with Part V requirements or not.476  
[424] On August 23, 1990, in a letter to Instrumentarium Inc., the Québec Regional Office of  
the Health Protection Branch, in the person of Francine Jacques (Gaudette), confirmed the recall  
actions including the “voluntary detention” of all Vitek Proplast implants for which a Notice of  
Compliance had not been issued.477 On October 4, 1990, certain units were returned to  
Instrumentarium Inc.478 The chronologies reviewed during the cross-examination of Lindsay  
473 Agreed Statement of Facts at para. 116 and Exhibit 70 at T. 11B  
474 The list at Exhibit 70 T. 11B is a second production of the memo of August 20, 1990 (the first being AGC-4489)  
has a different version of the list of sales. Whereas the list at AGC-4489 shows sales of 183; the list that is part of  
Exhibit 70 shows sales of 199 (the number passed on to Lindsay Blaney by Francine Jacques which is the number  
found in her hand writing on Exhibit 70 T. 3 and Exhibit 59 at T. 52 and for the English Translation also see:  
Exhibit 59 T. 52)  
475 Transcript of Francine Jacques (June 18, 2019) at p. 34  
476 Ibid at pp. 33-34  
477 Agreed Statement of Facts para. 117  
478 Ibid at para. 118  
Page: 144  
Blaney indicate that the recall was completed on or by October 3, 1990.479 On January 9, 1991,  
Instrumentarium Inc. informed Health and Welfare Canada of the completed recall of Vitek TMJ  
IPI implants. This included the number and type of Vitek TMJ Interpositional implant units  
returned by purchasers. There were 37 of them.480  
[425] Francine Jacques (Gaudette) was involved in the recall. During her testimony she was  
referred to Information Letter 661 which is dated May 14, 1988, is addressed to “All Recipients  
of Information Letters” and is entitled “Product Recall Procedures.481 She said:  
This letter is very specific. It contains all the details. It was used as a basis for  
our own general procedure. When we were looking at the recall procedure on the  
firm side, we would refer them to information letter 661 to…For the details. How  
they should proceed. It was like procedurethat.... 482  
[426] Information Letter 661 was used to advise those at Health and Welfare Canada of their  
responsibilities during a recall. It was not a regulation. It was guidance as to how they and  
industry participants should carry out a recall:  
The enclosed document entitled 'Product Recall Procedures' is currently being  
used by the Health Protection Branch to facilitate our internal recall  
responsibilities. I am, however, convinced that its contents can also be of benefit  
to the relevant industries and I encourage its acceptance by you as a basic  
guideline for the recall of food and drugs, cosmetics and devices. There is no  
intention to promulgate these recall procedures into regulations.483  
[427] It was made clear that the responsibility for developing a recall strategy lay with the  
company involved, in this case, Intrumentarium Inc.:  
It was the firm that was recalling the product. They had to develop their strategy,  
and they had to inform by regulation, they had to inform the Health Protection  
Branch that there was a recall ongoing if they were recalling a product, and then  
we would monitor the recall, the efficiency of their recall, and we would evaluate  
their recall strategy, was it was it correct, pertaining to a particular situation.  
We were there to see if it was acceptable and effective.484  
[428] Francine Jacques (Gaudette) confirmed that the process was monitored by the Health  
485  
Protection Branch.  
She was satisfied that the recall was effective, and that the method by  
479 Exhibit 71 at T’s 13, 14, 16 and 22  
480 Ibid at para. 119 and see Exhibit 70 T. 3 and Exhibit 59 T. 52 and for the English Translation also see: Exhibit  
59 T. 52  
481 Transcript of Francine Jacques (June 18, 2019) at p. 2 referring to Exhibit 60 T. 1  
482 Ibid at p. 9  
483 Ibid at p. 18 quoting Exhibit 60 T. 1  
484 Ibid at p. 19  
485 Ibid at p. 19  
Page: 145  
which Instrumentarium Inc. conducted the recall, which was to contact each surgeon directly,  
was an appropriate way to proceed:  
So, we were there …. I was there for the recall monitoring, 15 months later, 15-16  
months later, they do the recall. I think the way the[y] used representatives to  
contact the surgeons, the direct customers, was the best way to do [it]. It was an  
adequate way to do [it] for this type of product.486  
[429] In the circumstances, I do not think it of any value to disaggregate all of the actions taken  
by or on behalf of the Crown to determine whether each and every one of the specifics of  
Information Letter 661 (Product Recall Procedures) were followed. I repeat, it was a guideline.  
In this case the recall was proficiently carried out, by the company, with the guidance of  
representatives of Health and Welfare Canada. It was done in a short period of time and included  
an inventory of the products imported, retained, sold, recovered and possibly implanted.  
[430] The Plaintiff has cast a shadow over these events by submitting that there was product  
imported directly and not through Instrumentarium Inc. and that it is the fault of Health and  
Welfare Canada for not picking this up. I do not accept that there is sufficient substantive  
evidence to confirm this is true. If it is true, the efforts made to notify those engaged in  
implanting those devices of the problems associated with their use were appropriate and  
reasonable. At the outset of her cross-examination and later Francine Jacques (Gaudette)  
indicated that there was no evidence of anyone who had not been advised or received some form  
of the several notifications that had been undertaken. There was a “slight possibility” that such a  
person existed.487 She had not encountered a single example of what she termed “private  
importation”.488 Francine Jacques (Gaudette) had looked at the customs manifests. This is what  
caused her to review the database as to the status of the submissions made in respect of Vitek  
Inc. products. Dr. Daniel Tomlak was the only Canadian physician to testify. He had implanted  
Vitek Proplast implants. They were purchased from Instrumentarium Inc., which he understood  
to be a reputable corporation in the field of medical devices. Elliot Wayne Tunis implanted 58  
Proplast implants. They were purchased by the hospital. He used different types of Vitek  
Proplast products in different cases; some were specially ordered; others were kept in stock.489  
As in the case of Daniel Tomlak, the purchase of these implants was made through the head  
nurse who was in charge of obtaining required materials. It was the nurse who approached those  
at the hospital responsible for purchasing. At the time of the cross-examination, which was  
accepted as evidence in this case, a document was put to Elliot Wayne Tunis. It was exhibited as  
“Photocopy of Document Containing Entry Dated September 26, 1985 (The Ordering of a  
Proplast Vitek 913.46 Fossa TMJ Prosthesis)”. The Exhibits were not produced with the  
Transcript. There is no way of knowing if this document would have provided information as to  
who sold the implant to the hospital. This is one place where the probative value of the cross-  
examination of Elliot Wayne Tunis becomes an issue. There is nothing concrete that suggests the  
implants he used were imported directly from Vitek Inc. To the contrary, the similarity with the  
486 Ibid at p. 47  
487 Ibid at p. 98  
488 Ibid at at pp. 99, 100 (“I did not encounter any instance where it had occurred.”)  
489 Transcript, Cross-Examination of Elliot Wayne Tunis on his affidavit sworn August 1, 2007 at pp. 61-63 and 67  
Page: 146  
circumstances of Daniel Tomlak suggests the purchase was from the only Canadian distributor,  
Intrumentarium Inc.  
[431] From April 1, 1991 to October 1, 1991 Francine Jacques (Gaudette) was seconded to be  
the Supervisor of Drug Inspectors and, for that period was not responsible for the  
Instumentarium Inc. file. For that time that responsibility was passed on to Denise Coté. 490 On  
December 9, 1991 Denise Coté sent a memo to Lindsay Blaney which included the following  
sentence:  
In addition, it should be kept in mind that “X” number of implants may have been  
imported directly from the United States.491  
[Emphasis added]  
[432] The use of the word “may” does nothing more than raise this as a possibility in the  
absence of any supporting material.  
[433] On October 16, 1992 Francine Jacques (Gaudette) had returned to her responsibilities as  
an inspector in respect of medical devices. On that day she prepared a memorandum which  
reviewed the actions that had been taken by the Health Protection Branch as “summarized” in the  
memo of December 9, 1991 written by Denise Coté. The memorandum prepared by Francine  
Jacques (Gaudette) included a recommendation:  
It would appear necessary for the department to send a letter to all physicians and  
dentists in Canada to ensure that all those affected are aware of the importance of  
patients with Vitek and OSMI TMJ IPIs VK, VK-I and VK-II implants being  
examined. The Department could use this opportunity to include a note about  
Vitek’s other implants whose notices of compliance were revoked as a result of  
the bankruptcy. A sample letter could be sent with the latest FDA notice is  
attached. 492  
[434] The rationale for this recommendation is one of a series of recitals (whereas clauses) that  
lead to it:  
Whereas it seems certain that it was possible to purchase this product directly  
from the United States and it was in that case not covered by this recall conducted  
by Instrumentarium.  
[Emphasis added]  
490 Transcript of Francine Jacques (June 18, 2019) at p. 62  
491 Exhibit 60 T. 5  
492 Exhibit 65 (English) and see Exhibit 59 T. 64 (French) The English translation is dated “September 92”.  
Apparently, the correct date, as appears on the French original is October 16, 1992.  
Page: 147  
[435] This is from an English translation of a memorandum originally written in French. Even  
accounting for the vagaries of relying, in too refined a way, on a translation, the idea that it  
“seems certain” that some act was “possible” is a considerable distance from a concrete  
demonstration that the thing, whatever it might be, actually happened.  
[436] The Submissions of the Plaintiff note this “letter” as saying “…that there was an  
unknown quantity of implants that had been purchased from the U.S.”493 The memorandum  
(“letter”) does not say that. It says what is quoted above. In her evidence Francine Jacques  
(Gaudette) said that there was a concern for the possibility of private, direct importation to  
doctors on the list of 200 Canadian doctors. She went on to say that none was ever identified:  
Yeah. After I became aware that they had seized [a list] of 200 doctors, Canadian  
doctors…I thought we, we had the thought that maybe there would have been one  
of them that would have got the product, but I never encountered any proof of  
that.  
THE COURT: Okay  
It does not mean that it did not occur, but I have never seen any indication that it  
was the case.  
THE COURT: All right Mr. Steeves.  
MR. STEEVES: Q. And is it possible that more than one doctor could have  
engaged in a private importation?  
That’s all speculation and maybe there was none because what was this, this used  
for, I don’t know and the FDA did not know.494  
[437] This does not, as the Submissions of the Plaintiff imply, raise the spectre of untold  
numbers of privately imported implants. The Submissions of the Plaintiff declare that it should  
have been clear to Francine Jacques (Gaudette) that there had been private importing of Vitek  
Proplast implants. The Submissions refer to a report prepared by Francine Jacques (Gaudette)  
following her visit to Instrumentarium, Inc. on August 21, 1990 made in conjunction with the  
recall. The report is dated August 23, 1990. The report includes handwritten notes of Lindsay  
Blaney which, among other things, identify that 199 such implants had been sold by  
Instrumentarium Inc. This number is broken down to show 68 sold in British Columbia, 34 sold  
in Alberta, 95 sold in Ontario and 2 sold in Nova Scotia. The Submissions of the Plaintiff turn to  
a memo attributed to Robert Scales A/Medical Device Specialist, Health Protection Branch,  
Winnipeg, Manitoba.495 The memo refers to a Manitoba physician (no name is noted) that  
implanted two Proplast implants. From this the Submission concludes:  
493 Submissions of the Plaintiff at para. 423  
494 Transcript of Francine Jacques (June 20, 2019) at p. 9  
495 Exhibit 59 T. 42  
Page: 148  
Given Instumentarium’s customer records noted above [the breakdown referred  
to], this Manitoba surgeon secured these implants through private importation.496  
[438] The memorandum of Robert Scales is clear. The two implants used by the Manitoba  
surgeon were not privately imported. Like the doctors in Thunder Bay they were purchased from  
Instrumentarium, Inc.:  
Three of the doctors had not implanted any of the devices and the other had  
implanted two of them. He indicated that no problems had occurred with the  
device. He had obtained the implants from Instrumentarium.497  
[439] Obviously, there is an error. Either the records of Instrumentarium Inc. were incomplete,  
the Manitoba implants were recorded but missed in the review, they were located through  
purchase in another province or the Memorandum of Robert Scales is inaccurate. There is no  
way of knowing where the error lies but there is no reason to jump, as the Submissions of the  
Plaintiff do, to the conclusion that these two implants were privately imported. What is clear is  
that if any implants were privately imported, there were very few.  
[440] On October 13, 1992, Francine Jacques (Gaudette) sent the following letter (memo) to  
the “Chief, Drug and Environmental Health Division” in each of five regions explaining that the  
recommendation that a letter be sent to all physicians and dentists in Canada had been passed on  
to the Field Operations Directorate. The justification was different. The recommended letter to  
“all physicians and surgeons” was not due to a concern for “private importation” but in  
furtherance of the following up of letters sent by the United States Food and Drug  
Administration to surgeons that had been returned because the addresses were incomplete:  
You will find attached envelopes containing the FDA Safety Alert relating to the  
above-mentioned recall that were originally sent by FDA to oral and maxillofacial  
surgeons located in your region and returned to FDA for incorrect addressing.  
You will note that the postal code is incomplete.  
Would you please try to locate the surgeons and forward them this important  
information. A suggestion of covering letter is attached.  
Please take note that FDA took this list of surgeons in Vitek’s file and it dates  
somewhat [sic]. For example, in Québec Region we discovered that some  
surgeons have moved and others retired. Vitek filed for bankruptcy in 1990 after  
the recall had been initiated. For your information a recommendation has been  
made to FOD that we advise every dentist and doctor in Canada about this Safety  
Alert.  
Please do not hesitate to contact the undersigned should you need any more  
information.  
496 Submissions of the Plaintiff at para. 440  
497 Exhibit 59 T. 42 and Transcript of Francine Jacques (June 21, 2019) at p. 51  
Page: 149  
Francine Jacques Gaudette498  
[Emphasis added]  
[441] This recommendation was not followed. It is not necessary that every recommendation  
made be followed in order to demonstrate that a duty of care, if one is found to exist, has not  
been breached. In this case, a relatively small number of doctors were involved, a relatively  
small number of the offending devices had been shown to have been implanted and only the  
possibility of private sales had been raised. It was reasonable to determine that communicating  
with “every dentist and doctor in Canada” was not appropriate. It is not difficult to surmise that  
the upset and alarm that such a broadly cast communication could cause would more than offset  
the chance of missing some unidentified and illegal direct sale. As it is, there is evidence that the  
primary request, in the correspondence from Francine Jacques (Gaudette), that letters to doctors  
returned due to incorrect addresses be resent was met. This being so, her correspondence  
achieved its stated purpose. On November 3, 1992, Sharon Noel, Food and Drug Inspector,  
Halifax wrote to Francine Jacques (Gaudette):  
As requested in your memo dated 13 October 1992, the following oral surgeons  
were resent the letters from FDA on 2 November 1992. I have also enclosed their  
new mailing addresses for your information.  
[442] The Submissions of the Plaintiff expresses a concern for the foundation of the decision  
not to send letters to each and every physician and surgeon in Canada. The suggestion was made  
that Francine Jacques (Gaudette) passed this recommendation on to “doctors and scientists  
within Health Canada’s scientific group to make on the basis of science or health information”499  
and that this decision was not made on that basis. First, Francine Jacques (Gaudette) did not pass  
this on to those who made the decision because they were doctors or scientist but because they  
were the ones who were responsible for making this decision. Secondly, as described above,  
those who made the decision had to go beyond science and health and consider the overall  
context in which all this took place. Thirdly, as will become clear, there were other efforts made  
to notify physicians and surgeons of the concerns with Vitek Proplast implants. And finally, it is  
not clear that the decision to which the Submissions of the Plaintiff refers concerned letters to be  
sent to physicians and surgeons. Rather it had to do with the publication of a news release related  
to a settlement of corresponding litigation in the United States:  
MR. STEEVES: Q. Madam Jacques, you said that when it came to decisions on  
whether the press release was to go further, you placed that in the hands of others.  
You did not have jurisdiction. It was not your role to determine national  
communication. Is that correct?  
A. It is correct. And if you look at letter that we discussed this morning, 661, the  
authority to go to a press release it is the assistant deputy minister that has the  
authority to do that.  
498 Exhibit 61A T. 41  
499 Submissions of the Plaintiff at para. 442  
Page: 150  
Q. So, I guess my question is, it appears that the determination not to go forward  
with this appears to be based on the fact that there was an inaccuracy with Vitek  
settlement data, not necessarily science. Is that what that email reads? And you  
received it.  
A. Yeah, I received it. That was not my decision and it was not a decision for me  
to take. As I said, I brought the point, I thought, to explain my recommendation  
and then it was not for me to decide. It was scientific decision to be taken by the  
scientists. Not for me. I think the inaccurate thing they are referring to is a  
settlement in the States. But I cannot speak to that further because I was not  
involved in that at all.500  
[443] Lindsay Blaney explained why this sort of broad general notification was not thought to  
be necessary in Canada while being undertaken in the United States:  
What we need to understand is that by the time Francine is sending me this memo,  
December 1991, the recall in Canada has been conducted. It was an effective  
recall. By that date, December 1991, we had three targeted public warnings in the  
relevant Canadian Health Practitioner Association Journals and Newsletter. I’ll  
say it again. There was one in the Canadian Dental Association Journal in April  
1991. There was another one in the Canadian Dental Association Journal in  
August 1991; and there was another one through Dr. Freeland’s letter in the  
November edition of the Canadian Association of Oral and Maxillofacial  
Surgeons.  
So, by that date in Canada, there was a recall that had been conducted. All  
surgeons, hospitals, had been made aware of this issue. They had been informed  
to conduct proper clinical follow-up care on their patients. We had a community  
of dental practitioners who were aware of this issue, and Vitek products were no  
longer sold in Canada.  
So, that’s the situation in Canada, and we’re dealing with 162 possibly implanted  
implants.501  
[444] These were not the only activities that responded to the difficulties associated with Vitek  
TMJ implants.  
[445] On January 7, 1991, the United States Food and Drug Administration issued a news  
release announcing its recall of Vitek TMJ implants and urging dental surgeons “to x-ray patients  
with these implants to determine whether they are experiencing complications” and if there were  
500 Transcript of Francine Jacques (June 18, 2019) at p. 131-132  
501 Transcript of Lindsay Blaney (September 20, 2019) at p. 34  
Page: 151  
no complications, to have patients re-examined every six-months.502 The next day (January 8,  
1991), the United States Food and Drug Administration advised state health officers, boards of  
pharmacy, state drug officials and state device officials about the recall of Vitek TMJ implants.  
The United States Food and Drug Administration again advised dental surgeons to re-examine  
patients with these implants and return any unused stock.503 On February 1, 1991, the United  
States Food and Drug Administration announced the reclassification of Vitek TMJ Implants as a  
Class I recall based on a study of the composition of the implant material and evaluations of  
patients who reported complications from the implants.504 A Class I recall involves situations “in  
which there is a reasonable probability that the use or exposure to, a violative product will cause  
serious adverse health consequences or death.”505  
[446] By letter dated March 29, 1991, sent separately, to both Dr. E. LeTourneau,  
Environmental Health Directorate and Dr. D. L. Johnson, Bureau of Medical Devices, the United  
States Food and Drug Administration advised the Health Protection Branch of the Class I recall.  
The letter is a demonstration of the recognition and need for international cooperation in the  
circumstances such as this. I quote it in full:  
Dear Dr. [LeTourneau/Johnson]  
At the 1986 International Conference for Medical Device Regulatory Authorities  
(ICMDRA) there was a broad consensus regarding the need for communication  
and cooperation among government officials with national responsibility for  
medical devices.  
In the spirit of ICMDRA, I would like to inform you of a Class I recall conducted  
by the Vitek, Inc. Under the U. S. System the recall is conducted by the firm, but  
is monitored by the Food and Drug Administration (FDA). In the case of a Class I  
recall, i.e. One where there is significant risk to patient health, the firm is  
required to account to FDA for every item effected [sic] by the recall.  
The Vitek Inc., recall was initiated because FDA had determined that the failure  
of these devices could expose patients to a high degree of serious adverse health  
consequences including bone degradation and foreign body response by the  
immune system. Enclosed are copies of an FDA Safety Alert and a press release  
which fully describes problem and corrective action necessary.  
Some of the goods affected by this recall were shipped to consignees in your  
country. If you have any questions, please contact [the bankruptcy trustee for  
Vitek and a FDA official are named].  
502 Agreed Statement of Facts at para. 63  
503 Agreed Statement of Facts at para. 64  
504 Ibid at para. 65  
505 Ibid at para. 65  
Page: 152  
The Center for Devices and Radiological Health (CDRH), FDA, has been  
designated the WHO Collaborating Centre for Training and Consultation in the  
Public Health Aspects of Medical Devices. We look forward to international  
cooperation in the efforts to promote the safe and effective use of medical  
devices.  
Sincerely yours,506  
[Emphasis added]  
[447] Typically, the elevation of a recall from Class II to a Class I recall would be a matter of  
significance. The classification of recalls is reviewed in Information Letter 661 (“Product Recall  
Procedures”):  
“Recall classification” means the numerical designation, i.e. Class I, Class II, or  
Class III, assigned by the Health Protection Branch to a particular product recall  
to indicate the relative degree of health hazard presented by the product being  
recalled.  
(1) Class I is a situation in which there is a reasonable probability  
that the use of, or exposure to, a violative product will cause  
serious adverse health consequences or death.  
(2) Class II is a situation in which the use of, or exposure to, a  
violative product may cause temporary adverse health  
consequences or where the probability of serious adverse health  
consequences is remote.  
(3) Class III is a situation in which the use of, or exposure to, a  
violative product is not likely to cause any adverse health  
consequences.  
[448] The change from Class II to Class I reflects the recognition that something which had  
been thought to represent a probable risk of only temporary consequences, in fact, poses a threat  
of serious adverse consequences. The letter to Drs. LeTourneau and Johnson described that, with  
the change, there was a requirement to account for “every item effected [sic] by the recall”. By  
this time, in Canada, this was already known.  
[449] During April 1991, Francine Jacques (Gaudette) was contacted by Denise Coté. This was  
at the time Francine Jacques (Gaudette) was acting as supervisor of the Drug Inspection Unit and  
responsibility for the Instrumentarium Inc. file had been passed on to Denise Coté. Benoit  
Toupin, Supervisor, Medical Devices Unit for the Québec Region, had been told, by a memo  
506 Exhibit 70 T. 5 and Exhibit 60 T. 3 as well as Agreed Statement of Facts at paragraph 66. It is referenced at  
Transcript of Francine Jacques (June 18, 2019) at pp. 65-66  
Page: 153  
dated April 23, 1991, that in the United States the recall had been converted to a Class I recall.507  
This was considered by Francine Jacques (Gaudette) to be an important document. The fact of  
the reclassification from a Class II to Class I recall was important information.508 I will turn to  
the response of Health and Welfare Canada shortly.  
[450] There were further efforts to notify those involved in the implanting of Vitek Proplast  
devices.  
[451] On January 28, 1991, Health and Welfare Canada asked the Canadian Dental Association  
(“CDA”) to publish in its Journal a communication from the Health Protection Branch and  
Vitek’s Voluntary Safety Alert of March 23, 1990.509 The letter makes clear the purpose behind  
the request. It said, in part:  
I would like to thank you Dr. Crawford, and the Canadian Dental Association”  
for your cooperation in this matter as your journal is an excellent vehicle to  
expose your members to this information, which otherwise they may have  
overlooked.510  
[452] The Voluntary Safety Alert of March 23, 1990 was reprinted in the Canadian Dental  
Association Journal in April 1991 (Vol. 57 No. 4).511 It was introduced through a Health  
Protection Branch Communication, the first sentence of which restated the purpose of publishing  
the Voluntary Safety Alert:  
The Health Protection Branch (HPB) wishes to ensure that every dental surgeon  
concerned is made aware of the following Voluntary Safety Alert issued by Vitek  
Inc. in 1990.512  
[453] Prior to the request for the reprinting of the Voluntary Safety Alert in the Canadian  
Dental Association Journal, the United States Food and Drug Administration issued its own  
notice. This one was a FDA Safety Alert subtitled: “Serious Problems with Proplast Coated TMJ  
Implant”.513 It is dated December 28, 1990 and is addressed to “Oral and Maxillofacial  
Surgeons” and advised that:  
This is to urge you to re-examine all of your patients who have received  
temporomandibular joint (TMJ) interpositional implants which were  
manufactured or marketed by either Vitek Inc. or Oral Surgery Marketing Inc.  
(both of Houston Texas). These implants were distributed between February 1983  
and June 1988 and were the subject of Vitek’s March 23, 1990 safety alert.  
507 Transcript of Francine Jacques (June 18, 2019) at pp. 63-64 and Exhibit 60 T.3  
508 Ibid at p.64  
509 Agreed Statement of Facts at para. 120  
510 Ibid see footnoted document  
511 Exhibit 70 at T. 10  
512 Ibid  
513 Exhibit 70 T. 4 also at Exhibit 49 T. 14  
Page: 154  
[454] It stated the problem as:  
These implants, all of which are made of ProplastR (TeflonR, carbon or TeflonR -  
aluminum oxide fiber composite), have been associated with implant perforation,  
fragmentation and/or a foreign body response that may result in progressive bone  
degeneration of the mandibular condyle and/or glenoid fossa (1-3). If bone  
degeneration continues unchecked, patients may experience intense pain and  
severely limited joint function. One study found that all patients with ProplastR -  
coated TMJ interpositional implants who experienced complications  
demonstrated progressive bone degeneration in as little as 1 to 2 years (1). In a  
second study, implant failure and bone degeneration occurred in both  
symptomatic and asymptomatic patients (2).  
[455] The footnotes internal to this paragraph (the numbers (1) and (2)) refer to two academic  
papers which are said to support the points, in the quotation, with which they are associated. The  
first is dated May 1987 and the second May 1989.514 These are both MastersThesis and do not  
appear to have been published.  
[456] The FDA Safety Alert goes on to include recommendations as to how the patients with  
these Vitek TMJ Interpositional Implants should be examined and, depending on the results,  
followed up and treated.  
[457] I return to the response of Health and Welfare Canada to the reclassification, by the  
United States Food and Drug Administration, of the recall from a Class II to Class I recall. The  
reclassification in the United States to a Class I recall was a catalyst for the further notifications  
that continued after the recall by Instrumentarium Inc. had been completed.515 This is contrary to  
the position adopted in the Submissions of the Plaintiff which states:  
In the U.S., however, the FDA expanded their public health advisory to include  
all Proplast TMJ or IPI implants, including the VK and VKI implants. In Canada,  
there was no expansion of the recall. At the time of her 1990 visit, Ms. Jacques  
detained those items that didn’t have a notice of compliance. See Exhibit 49 tab  
30. This meant that the Proplast block and sheeting which could be used for TMJ  
514 Footnote (1) refers to: Primley, Donald, Jr. "Histological and Radiographic Evaluation of the Proplast-Teflon  
Interpositional Implanted in Temporomandibular Joint Reconstruction Following Meniscectomy, Thesis, Masters  
Degree in Oral Maxillofacial Surgery, May 1987. University of Iowa  
Footnote (2) refers to: Westlund, Kurt., "An Evaluation Using Computerized Tomography of Clinically  
Asymptomatic Patients Following Meniscectomy and Temporomandibular Joint Reconstruction Using the Proplast-  
Teflon Interpositional Implants", Thesis, Masters Degree in Oral and Maxillofacial Surgery, May 1989. University  
of Iowa  
515 Transcript of Francine Jacques (June 18, 2019) at pp. 64-74  
Page: 155  
interpositional implants, and the VK type Proplast TMJ devices, all of which had  
NOCs, were never detained, and continued to be distributed for use in Canada.516  
[458] To my mind this paragraph is, in part, misleading and, in part, wrong. There was no  
reclassification of the recall because at that point there was not one. The recall had been  
completed earlier on October 3, 1990 (see para. [424] above). Nonetheless, as will be described,  
there was considerable continued effort to notify those involved. Moreover, as I have already  
reviewed, “the TMJ interpositional implants, and the VK type Proplast TMJ devices” did not  
receive Notices of Compliance. So far as I am concerned the suggestion that these devices had  
received such notices is a fundamental flaw in the position taken of behalf of the Plaintiff which  
is repeatedly relied on in the submissions made on her behalf. As for Block and Sheeting, the  
intention was that their use be limited to facial and not orthopaedic issues. To the extent that the  
applicable product monograph could be misread (there is no example of this having happened)  
the uses the monograph describes are broad and general leaving it to the oral surgeon to decide  
whether or not the contraindications apply to a particular patient.  
[459] With the FDA Safety Alert in hand, Denise Coté discussed the situation with Francine  
Jacques (Gaudette). She followed up with Lindsay Blaney; they spoke on the telephone. Denise  
Coté confirmed the conversation in a handwritten Memorandum:  
News release-Safety alert regarding Vitek TMP IPIs  
I am writing to follow up on our telephone conversation of May 16, 1991,  
regarding the suggestion to publish a copy of the FDA safety alert (December 28,  
1990) in the journal of the Canadian Dental Association.  
Once you have made a decision, I will notify Instrumentarium of our plan, where  
necessary.  
Pease find attached a proposed text for publication in the journal.517  
[460] On June 4, 1991 the Health Protection Branch requested that the Canadian Dental  
Association publish, in its Journal, a second message concerning Vitek’s TMJ IPI devices along  
with the FDA’s December 28, 1990 Safety Alert. The message referred to is included in the  
request as:  
The Health Protection Branch wishes to ensure that every dental surgeon  
concerned is made aware of the second Safety Alert (see below) issued by the  
Food and Drug Administration of the United States on December 28, 1990. The  
first Alert had been published by Vitek Inc. on March 23, 1990. 518  
516 Submissions of the Plaintiff at para. 417  
517 Exhibit 60 at T. 4  
518 Agreed Statement of Facts at para. 123 and Exhibit 70 at T.6. The message is, as proposed by Denise Coté,  
included with her Memorandum of May 16, 1991 (Exhibit 60 at T. 4 )  
Page: 156  
[461] The FDA Safety Alert was reprinted in the Canadian Dental Association Journal in  
August 1991 (Vol. 57 No. 8) in both French and English.519  
[462] On June 18, 1991, the BRMD [Bureau of Radiation and Medical Devices] received, from  
the United States Food and Drug Administration, a copy of the list of Canadian consignees”  
(doctors and surgeons) who, it was said, had purchased the Vitek TMJ IPI devices.520 This was  
further to advice that had been provided three weeks earlier, on May 28, 1991 at a Tripartite  
Meeting involving representatives of the United States Food and Drug Administration, the  
United Kingdom’s Department of Health and Social Security and Health and Welfare Canada,  
when Canadian officials were advised by their American counterparts of a list of “Canadian  
consignees who had purchased devices, including but not limited to Vitek TMJ implants”.521  
This was also further to the letters dated March 29, 1991 from the United States Food and Drug  
Administration to both Dr. E. LeTourneau, Environmental Health Directorate and Dr. D. L.  
Johnson, Bureau of Medical Devices which noted that product of concern had been shipped to  
Canadian consignees (see: para. [446] above). In a handwritten memo to file (“Dossier”) Denise  
Coté advised that the list had been transmitted to the Association of Oral and Maxillofacial  
Surgeons.522  
[463] On or around June 25, 1991, Instrumentarium Inc. advised Health and Welfare Canada  
that it was no longer selling certain Proplast products in Canada.523  
[464] On September 6, 1991, a letter signed by W. Freeland M. D. as the Acting Chief, Clinical  
Advisory Division of the Health Protection Branch of Health and Welfare Canada was delivered  
to Dr. Aron Gonshor President, Canadian Association of Oral and Maxillofacial Surgeons. The  
letter refers to the voluntary recall of interpositional implants manufactured and marketed by  
Vitek Inc. in the United States (the Voluntary Safety Alert of March 23, 1990); to the fact that  
these implants were never given a Notice of Compliance by Health and Welfare Canada for sale  
of those devices in Canada and to the information recently received from the United States Food  
and Drug Administration identifying “that about 200 Canadian Dentists/Oral Surgeons received  
these devices for implantation in their patients in Canada”.524 In her viva voce evidence, more  
than once, Lindsay Blaney, expressed doubt that each of the 200 “consignees” had, in fact,  
purchased interpositional implants manufactured by Vitek Inc. She noted that only 199 of these  
implants had been sold by Instrumentarium (the sole Canadian distributor) and “possibly” 162 of  
these devices had been implanted.525 This being so it seems unlikely that all 200 of the  
consignees had purchased interpositional implants manufactured by Vitek Inc. Lindsay Blaney  
indicated that the people at Health and Welfare Canada (“we”) were unsure as to what was meant  
by the word “consignees”:  
519 Exhibit 70 at T. 10  
520 Agreed statement of Facts at para. 124 and Exhibit 70 T. 7  
521 Ibid at para. 67  
522 Exhibit 70 at T. 8  
523 Agreed Statement of Facts at para. 125  
524 Ibid at para. 126 and Exhibit 70 at T. 9  
525 Exhibit 70 T. at 3 and Exhibit 59 T. 52 and for the English translation also see: Exhibit 59 at T. 52)  
Page: 157  
We don’t really know what they meant by that word because we eventually came  
to the realization that not all names on that list had purchase[d] implanted the  
devices.526  
[465] She posited that the 200 listed consignees were Canadian oral surgeons who had  
expressed an interest in the product and not those who had purchased any:  
So it appears like this is what it might have been, a list of oral surgeons that were  
on their mailing list and interested in receiving any information on their  
products.527  
[466] Be that as it may, the fact is that the letter of September 6, 1991 was sent to Dr. Aron  
Gonshor with the request that it be published in the Newsletter of the Canadian Association of  
Oral and Maxillofacial Surgeons.528 As it transpired the letter of September 6, 1991 was  
misplaced during a postal strike. Another copy was faxed to Dr. Aron Gonshor on October 10,  
1991 “for publication”.529 Lindsay Blaney testified, and the documents indicate, that the letter  
was published in the November, 1991 issue of the Canadian Association of Oral and  
Maxillofacial Surgeons Newsletter. It followed what was referred to as an “IMPORTANT  
NOTICE”:  
The legacy of the Vitek temporomandibular joint prosthesis continues, although  
the company and the product are no longer around. A recent letter from the  
Bureau of Radiation and Medical Devices, Health and Welfare Canada, is  
reproduced below for your information and action if appropriate. If there are any  
questions regarding management of any of your patients in regard to the  
prosthesis, inquiries can be directed to:  
[The name, address and phone number of a Consultant Physiologist with the  
Clinical Advisory Division, Bureau of Radiation and Medical Devices were  
provided.] 530  
[467] In furtherance of the idea that the list did not demonstrate doctors who purchased, but  
those who may have expressed an interest, I note that a year later, on September 16 and 18, 1992  
Francine Jacques (Gaudette) tried to contact all the oral and maxillofacial surgeons in Quebec  
whose names were on the list of “about 200” received from Vitek Inc. By my count there were  
29 doctors from Quebec on the list. She managed to reach 7, not one of whom had implanted  
526 Transcript of Lindsay Blaney (September 17, 2019) at p. 74  
527 Ibid at p. 74 (Health Canada was advised of the existence of the list at the tripartite meeting of the United States  
Food and Drug Administration, the United Kingdom Department of Health and Social Security and Health Canada  
(Agreed Statement of Facts at para. 67). It was in June 1991 that Health Canada received the list (Transcript of  
Lindsay Blaney (September 19, 2019) at pp. 52-53))  
528 Exhibit 70 at T. 9  
529 Exhibit 70 at T. 12  
530 Exhibit 70 at T. 10  
Page: 158  
“the device.”531 Interestingly, they were all aware that problems with Proplast implants had  
appeared, some through the notices from the United States Food and Drug Administration and  
others through the publication of these concerns in various journals. I repeat that on October 13,  
1992 Francine Jacques (Gaudette) sent a letter to the five regions requesting that where the  
letters to these “consignees” had been returned, follow up letters be sent. This direction was  
followed (see para. [441] above). This tends to confirm the likelihood that all of the health  
professionals involved with these products had already been alerted to the difficulties that had  
become apparent.  
[468] As testified to by Lindsay Blaney, the recall was complete. Even so, there was a further  
notification to ensure that oral surgeons undertook to, and did follow up, with their patients who  
had received Vitek Inc. temporomandibular implants. Concerns did not end with the completion  
of the recall. In the United States the recall had been applied only to interpositional implants  
referred to in the Safety Alert of December 28, 1990. The interest now extended to a broader  
range of Vitek implant products.  
[469] In September 1991, the United States Food and Drug Administration issued Public  
Health Advisories on Vitek Proplast TMJ implants to health professionals, patients and Vitek  
consignees. These advisories were not limited to interpositional implants but also related to VK  
(glenoid fossa), VK-1 (condylar head, glenoid fossa) and VK-II implants. The advisories sought  
to identify all patients with the implanted devices and have them re-examined and monitored.  
The advisories indicated that the United States Food and Drug Administration considered the  
implanted devices to “present a hazard to the health of patients” and advised that a special  
registration program for all Vitek TMJ patients had been established.532  
531 Exhibit 63 (Memo: “Conversations With Oral Surgeons”) in particular see p. 2: “No one said they had implanted  
the device.”  
532 Agreed Statement of Facts at para. 68 referencing AGC-04890 (Dear Health Professional and Vitek Consignee)  
also see Exhibit 49 at T. 30 (Dear Health Professional)  
While the catalogue numbers associated with the material filed in support of the request for Notices of Compliance  
demonstrate that, in Canada, there was a distinction between Vitek Interpositional Implants as opposed to TMJ  
Fossa Prosthesis, Type VK and TMJ Condylar Prosthesis, Type VK (see: Exhibit 12 at T. 32 at pp. 000012 and  
000013) it is not so clear that the difference was part of the treatment extended to these products by the United  
States Food and Drug Administration. I say this because AGC-04890 relied on in the Agreed Statement of Facts  
begins:  
Dear Health Professional and Vitek Consignee:  
The United States Food and Drug Administration (FDA) request that you notify all patients of the  
problems associated with the following temporomandibular joint (TMJ) interpositional implants  
manufactured by Vitek, Inc., Houston Texas:  
TMJ interpositional implant (IPI)  
VK (glenoid fossa)  
VK-I (condylar head, glenoid fossa)  
The concerns about the IPI or expressed in FDA's December 28, 1990 Safety Alert (copy  
enclosed).  
Page: 159  
[470] During October 1991, the American Academy of Oral and Maxillofacial Surgeons  
published in its “Digest” the United States Food and Drug Administration’s September 1991  
Public Health Advisory on Vitek Proplast TMJ implants.533  
[471] In the same month (October 1991), the United States Food and Drug Administration:  
published an article in the “Medical Devices Bulletin” about risks associated with  
TMJ implants. The article stated that on October 2, 1991, the United States Food  
and Drug Administration advised patients with Vitek TMJ IPI devices to be  
examined and monitored by their surgeons or dentists and further advised about  
the establishment of the registration program for all Vitek TMJ patients;534  
on October 2, 1991, issued a “Medical Alert” and a press release concerning the  
risks associated with Vitek TMJ IPI devices and of the registration program that  
had been established. The press release recommended that patients obtain an  
immediate examination to determine whether the implants were breaking down or  
causing bone degeneration;535 and  
on October 28, 1991, informed foreign regulatory agencies of Vitek TMJ IPI  
device sales within their countries and remedial measures that it had taken  
To my mind, this is at best ambiguous as to whether Interpositional Implants stand apart or are an all-inclusive term.  
It would seem that Doran Ryan in the Expert Report he filed (Agreed Statement of Facts at Tab 20 p. 28) does not  
share this concern:  
Also, in September 1991 the US FDA issued a Public Health Advisory superceding the 1990  
Safety Alert and containing specific recommendations for the follow-up of patients who had  
received Proplast-Teflon IPIs as well as Vitek genoid fossa and condylar implants.  
This uncertainty does not exist in the second of the two documents referred to in the Agreed Statement of Facts at  
para. 68 being AGC-04892 which begins:  
Dear TMJ Patient:  
This letter contains important health information for persons who have or have had jaw implants  
manufactured by Vitek these include the temporomandibular joint (TMJ) interpositional  
implants (IPI), VK and VK-I. The information contained in this letter also applies to individuals  
with a VK-II TMJ implant manufactured by Oral Surgery Marketing Inc., a successor  
corporation of Vitek.  
533 Agreed Statement of Facts at T. 20 (Dr. Doran Ryan Expert Report) p. 29  
534 Ibid at para. 70  
535 Ibid at para. 71. Again, the Agreed Statement of Facts refers only to "Vitek TMJ IPI devices" where the first of  
the two documents speaks of "certain jaw implants manufactured by Vitek Inc. of Houston…" The second document  
mentions a broader array of Vitek TMJ implants:  
The implants in question include Vitek interpositional (IPI), Vitek-Kent (VK), and Vitek-Kent I  
(VK-I) TMJ implants….[and]…VK-II TMJ implant…  
Page: 160  
namely: the establishment of a notification program to identify and notify both the  
surgeons who had implanted the devices and the patients who received them;  
advising patients to seek regular appropriate medical examination; and the  
initiation of an international patient registry, which would allow the United States  
Food and Drug Administration to contact patients and surgeons to relay new  
information to them as soon it became available.536  
[472] On December 1, 1991, the United States Food and Drug Administration issued a  
“Medical Bulletin” notifying physicians and patients about risks associated with Vitek implants  
and the need for diagnostic examinations of patients. It also provided information on how to  
enroll in the international patient registry.537  
[473] On May 29, 1992, the United States Food and Drug Administration issued an “Important  
Alert” for “implantable devices consisting in whole or in part of Proplast, Proplast II, or Proplast  
HA.538 In August 1992, the American Academy of Oral and Maxillofacial Surgeons circulated a  
TMJ Implant Advisory.539 In November 1992, the American Academy of Oral and Maxillofacial  
Surgeons convened a workshop in Chicago to review the knowledge, use and management of  
alloplastic TMJ implants.540 In July 1993, the American Academy of Oral and Maxillofacial  
Surgeons redistributed its TMJ implant advisory, originally published in August 1992, to United  
States and Canadian fellows, members, life and retired members, candidates, residents and  
affiliate members. The advisory included the United States Food and Drug Administration’s  
current recommendations on Vitek’s Proplast TMJ implants.541 In October 1993, the American  
Academy of Oral and Maxillofacial Surgeons published “Recommendations for the Management  
536 Agreed Statement of Facts at para. 72  
537 Ibid at para. 73. The first of these two documents is the Medical Bulletin. It refers to the broader array of Vitek  
Implants:  
The Implants in Question Include the Vitek Interpositional (IPI), Vitek-Kent (VK), and Vitek-  
Kent I (VK-I) TMJ implants. Oral Surgery Marketing, Inc. (OSMI), of Houston, a successor  
corporation of Vitek also manufactures a VK-II implant that may present similar risks.  
A search of the second document (Retrieval Analysis Study) does not reveal any reference to either the date  
(December 1, 1991) or to any "Medical Bulletin".  
538 Ibid at para. 74  
539 Ibid at para. 75  
This document appears to deal with all Vitek Proplast TMJ implants. It begins:  
Prompted by problems resulting from the Vitek Proplast Teflon TMJ implants, the House of  
Representatives government operations human resources and intergovernmental relations  
subcommittee held a hearing on June 4, 1992, in Washington, DC. The focus of the hearing was  
whether the Food and Drug Administration (FDA) and National Institute of Health (NIH) have  
failed to act appropriately to protect the public from the inadequacies of TMJ implants.  
540 Ibid at para. 76 and T. 24 (Retrieval Analysis Study)  
541 Ibid at para. 77  
Page: 161  
of Patients with Temporomandibular Joint Implants” in the Journal of Oral and Maxillofacial  
Surgery, based on the workshop that had occurred in November 1992.542  
[474] What is plain from the preceding paragraphs is that in the period following the closing of  
the Canadian recall (be it on October 3, 1990 as reported in the chronologies or January 9, 1991  
when Instrumentarium notified Health and Welfare Canada) the continued use and impact of a  
larger grouping of Proplast TMJ implants remained of interest and concern, particularly in the  
United States.  
[475] By 1994, as testified to by Lindsay Blaney, more information was available with respect  
to temporomandibular joint implants. The concern in the United States extended beyond Vitek  
Inc. to all alloplastic TMJ implants. This was manifested in a letter dated July 15, 1994 from the  
Director, Center for Devices and Radiological Health to: “Orthopedic Surgeons,  
Otolaryngologists, Plastic and Reconstructive Surgeons”. It begins:  
The Food and Drug Administration (FDA) is aware that you may see patients who  
have received temporomandibular joint (TMJ) implants. We are writing to inform  
you about the potential problem with these implants.  
Enclosed is a copy of the 1990 FDA Safety Alert sent to all U. S. oral and  
maxillofacial surgeons urging them to re-examine their patients with ProplastR -  
coated TMJ implants. This Alert describes the signs and symptoms of problems  
associated with ProplastR -coated TMJ implants and provides recommendations  
for management of patients. We request that you follow the recommendations in  
the Alert in evaluating your clients with these types of implants. In addition, the  
American Academy of Oral and Maxillofacial Surgeons (AAOMS) published  
recommendations for management of patients with TMJ implants in its  
professional journal in October 1993. These recommendations address the  
management of patients with the following three types of alloplastic TMJ  
implants: Teflon-ProplastR interpositional implants, total joint prosthesis with a  
Teflon-ProplastR fossa and SilasticR TMJ implants.  
[476] The letter goes on to observe:  
Practitioners who become aware of device-related deaths, serious illnesses and/or  
serious injuries are asked to notify FDA.  
And:  
The Safe Medical Devices Act of 1990 (SMDA) requires hospitals and other  
facilities to report deaths, serious illnesses and injuries associated with the use of  
542 Ibid at para. 78  
Page: 162  
medical devices. You should follow the procedures established by your facility  
for such mandatory reporting.543  
[477] The question that arose was how, or if, Health and Welfare Canada should respond to this  
broader concern. The Medical Devices Management Committee met on August 15, 1994. The  
mandate of the committee was to review and discuss issues that arose in the context of the  
Bureau of Medical Devices. The minutes of the meeting report as follows:  
Dr. Magwood described the recent actions of the U.S. FDA with regard to the  
problem of Vitek implants. The FDA has recently sent a Dear Doctor letter to  
additional professional agencies describing the problems associated with Vitek  
implants.  
In 1991 the Bureau informed Dental and Maxilla-Facial surgeons [sic] of the  
problems associated with the use of the non-compliant devices. However many  
calls have been received recently as a result of the wider audience currently  
receiving the U.S. FDA information.  
Dr. Neufeld responded that the Bureau has the names of 200 professions [sic]  
supplied with the devices in Canada prior to 1991. Dr. Tobin requested that an  
Alert be drafted and that a mailing list be determined, including these 200  
names.544  
[478] Lindsay Blaney was asked to prepare a communication plan; which she did.545 Prior to  
this plan being completed, the Acting Director, Office of Standards and Regulations, Center for  
Devices and Radiological Health, part of the United States Food and Drug Administration wrote  
a letter, dated September 24, 1994, to those responsible for medical devices in other jurisdictions,  
including Dr. Richard S. Tobin, identified in the minutes of the August 15, 1994 meeting of the  
Medical Devices Management Committee as its chairman. The letter was passed on to Lindsay  
Blaney by Richard S. Tobin. I quote it in full:  
Dear Colleague:  
This letter is to alert to our concerns about devices manufactured using ProplastR,  
a composite material consisting of PTFE (polytetrafluoroethylene). We recently  
mailed a Public Health Advisory dated July 15, 1994, (copy attached), to  
physician’s groups which describes the signs and symptoms of problems patients  
have experienced associated with the devices manufactured of ProplastR p.  
ProplastR was developed by Charles Homsy, SC. D., for use in  
temporomandibular joint (TMJ) devices. We understand Dr. Homsy now resides  
in Switzerland and is employed by Promotus S. A., a Swiss medical device  
543 Exhibit 70 at T. 13  
544 Ibid at T. 14  
545 Ibid at T. 17  
Page: 163  
manufacturer. We have learned through an article in the London Financial Times,  
June 24, 1994, edition (copy enclosed) that Kobe Steel, a Japanese metals  
company, is seeking to join with Promotus S. A., who is developing a biomaterial  
for bone implants and artificial hip joints using ProplastR.  
We want to bring to your attention our concern over the use of ProplastR on any  
implant used in a loadbearing situation. Our experience shows that implants made  
of ProplastR have been associated with perforation, fragmentation and/or foreign  
body response which may result in progressive bone degeneration.  
Currently, various implantable devices consisting in whole or in part of Proplast,  
Proplast II, or Proplast HA are included on our Import Alert #89 10 for  
automatic detention, subject to refusal of admission into the United States. A copy  
of the Import Alert is provided with this letter.  
If you need more information, please contact [name, address and phone number  
provided]  
Sincerely yours546  
[479] The Import Alert to which the letter refers put in place an “Automatic Detention”.  
Among other products it included:  
Temporomandibular Joint (TMJ) Implants  
a. Glenoid Fossa  
b. Condyle  
c. Interpositional Implants547  
[480] As part of the action taken in response to the information delivered in the letter dated July  
15, 1994 (from the Director, Center for Devices and Radiological Health) to the professionals  
involved in the implantation and treatment of those receiving temporomandibular joint implants  
and the subsequent letter addressed to “Dear Colleague” dated September 24, 1994 (from the  
Acting Director, Office of Standards and Regulations), on September 29, 1994, there was the  
issuance, by Health and Welfare Canada, of a Canadian Import Alert:  
IMPORT ALERT  
94-02  
SUBJECT:  
546 Ibid at T. 15  
547 Ibid  
Page: 164  
Implants consisting in whole or in part of any type of Proplast material  
manufactured by Promotus S A, Switzerland, or any other manufacturer.  
BACKGROUND:  
The devices do not have a Notice of Compliance to be sold in Canada.  
GUIDANCE:  
The product should be refused entry at Customs. Canada Customs have been  
asked to detain shipments and call the nearest Health Protection Branch Office.  
NAME AND ADDRESS OF IMPORTERS:  
At the moment there are no known importers.  
COMMODITY:  
All implantable devices such as facial, temporomandibular, orthopedic, and  
custom implants, as well as blocks and sheets for facial and other reconstruction  
labelled as containing or being made of Proplast and being manufactured by  
Promotus S A or any other manufacturer are affected by this import alert.  
COUNTRY OF ORIGIN:  
The manufacturer of these implants is:  
Promotus S A  
Route de Divonne 48  
Nyon, Switzerland.  
POTENTIAL PORTS OF ENTRY:  
All ports of entry.  
SCOPE OF THE ALERT:  
National; effective immediately. This alert should remain in force until April 1,  
1995. The Health Protection Branch should be consulted before the alert is lifted.  
All shipments of these implants, including shipments to hospitals, for professional  
use, personal or commercial shipments are subject to this import alert.548  
548 Ibid at T. 16  
Page: 165  
[Emphasis added]  
[481] The communications plan developed by Lindsay Blaney first put the circumstances and  
situation in context:  
Following the 1990 recall, the Health Protection Branch requested the Canadian  
Dental Association and the Canadian Association of Oral and Maxillofacial  
Surgeons to inform their members of the problems associated with the Vitek jaw  
implants and the recommended monitoring of patients.  
The priority of the Health Protection Branch in cases such as this is to quickly  
remove defective products from the market. The voluntary recall and publication  
actions were taken as prudent measures to prevent possible harm from the use and  
distribution of the product.549  
[482] The communication plan outlined seven action items:  
1. Prepare an Advisory Letter to Physicians to reiterate the information on the problems  
associated with Vitek and other jaw implants and on the recommended procedure for  
treatment and monitoring.  
2. Request the professional medical journals to print the Advisory Letter to Physicians  
3. Make the Advisory Letter to Physicians available to the media on request.  
4. Provide patients who have received a Vitek or another jaw implant with an  
information package.  
5. Prepare a ministerial briefing for release following the broadcast of Marketplace [a  
CBC television program] on October 4, 1994.  
6. Update Questions and Answers to respond to inquiries from the public and the media.  
7. Put in place an import alert on all Proplast implants to prevent their entry in  
Canada.550  
[483] In order to ensure the broadest effort to inform professionals involved, a letter was  
prepared and, on October 12, 1994, sent to six professional organizations as follows: (1)  
Canadian Medical Association, (2) Canadian Orthopedic Association, (3) Canadian Dental  
Association, (4) Canadian Association of Oral and Maxillofacial Surgeons, (5) Canadian Society  
of Otolaryngology and Head and Neck Surgery and (6) Canadian Society of Cosmetic and  
Plastic Surgery.551  
549 Ibid at T. 17 at p. 2  
550 Ibid at T. 17 at p. 3  
551 Ibid at T. 18  
Page: 166  
[484] Richard S. Tobin sent a draft of an advisory letter to each of the six organizations to  
inform practitioners of concerns which affect patients with alloplastic temporomandibular joint  
implants and of recommended monitoring of those patients. The draft letter reads:  
Dear Doctor,  
Health and Welfare Canada understands that you may see patients who have  
received temporomandibular joint (TMJ) implants and wants to communicate this  
important information to you.  
The purpose of this letter is to inform you of concerns which affect patients with  
alloplastic TMJ implants. These implants may fragment, delaminate, or otherwise  
be damaged or punctured. Debris in the joint from alloplastic implants can  
contribute to progressive bone degenerative changes and to giant cell reaction. All  
patients, including asymptomatic patients, should be monitored closely to assure  
proper patient care. This monitoring should include clinical and radiographic  
examination. The radiographic examination may include transcranial or  
tomographic x-rays, CAT scans, bone scans or MRI investigations.  
You will find enclosed a copy of the Notice “IMPORTANT INFORMATION  
ABOUT TMJ IMPLANTS” recently re-issued by the U.S. Food and Drug  
Administration (USFDA) to practitioners who may be involved in the treatment  
and follow-up of patients who have received VitekR Proplast TMJ implants or  
other implants such as the SilasticR implant.  
Information on the possible complications associated with the VitekR TMJ  
implants and the recommended monitoring had previously been made available to  
all purchasers by the Canadian distributor. In addition, both the USFDA and  
Health and Welfare Canada disseminated information to medical and dental  
practitioners.  
Practitioners who become aware of device related problems are asked to report  
the problems to the Director, at the above-mentioned address or phone the toll-  
free Hot-Line number 1-800-267-9675. To assist the Department in reaching the  
patients who have received alloplastic TMJ implants, we would appreciate if you  
would encourage them to contact us at the above address or toll-free Hot-Line  
number. Your cooperation in this matter is appreciated.  
Sincerely,552  
[485] Accompanying the direction and the draft letter (in both French and English) was a  
package of material including, in both French and English, the July 15, 1994 letter (to  
Orthopedic Surgeons, Otolaryngologists, Plastic and Reconstructive Surgeons from the United  
States Food and Drug Administration), the FDA Safety Alert dated December 28, 1990 (also  
552 Ibid at T. 18 (AGC-05604)  
Page: 167  
both in French and English), the paper from the American Academy of Oral and Maxillofacial  
Surgeons entitled “Recommendations for Management of Patients with Temporomandibular  
Joint Implants” and the two notifications which had been printed in the Canadian Dental  
Association Journal (the Voluntary Safety Alert of November 23, 1990 and the FDA Safety Alert  
of December 28, 1990) as well as the letter to Dr. Gonshor dated September 6, 1991 and  
reprinted in the Canadian Association of Oral and Maxillofacial Surgeons Newsletter.553  
Although it is not one of the six organizations noted, Daniel Tomlak recalled receiving an alert  
from the Royal College of Dental Surgeons of Ontario at some point after his departure from  
Thunder Bay.554  
[486] On October 26, 1994, the Medical Devices Bureau sent the letter and a package of  
relevant material to the 182 names from the list of “consignees. The original list of 200  
consignees was, by then, a few years old. It was verified for accuracy with the provincial  
registrars of dentistry. Some on the original list were no longer in practice. Hence, the reduction  
to the 182 to whom the package was sent.555  
[487] Lindsay Blaney testified that each of the seven action items were undertaken and  
completed. Not only was the “Advisory Letter” drafted and sent on to the six professional  
associations for distribution to their members, it was accompanied by a direction entitled  
“Advisory Letter to Practitioners Re: Temporomandibular Joint Implants” which included the  
request that they:  
…make this information available to your members via your journal or other  
mechanisms in place to disseminate information to your membership”.556  
[488] It follows, and I accept, that the “Advisory Letter to Physicians” was or would have been  
made available to the media, if requested. Thus, of the seven items in Lindsay Blaney’s action  
plan, numbers 1, 2 and 3 were satisfied. I should also point out that this was another  
circumstance in which Francine Jacques (Gaudette) suggested that a broad group of doctors, in  
this case the individual members of each of these organizations, should receive notice of the  
identified concerns. A memo from Hripsime Shahbazian dated December 13, 1995 notes, in part:  
As well Francine has suggested that the information package sent to the  
associations should also be sent to each member of that Association to make sure  
that they are aware of this issue.557  
553 Ibid at T. 18  
554 Transcript of Daniel Tomlak (May 21, 2019) at pp. 78-79: It appears that Daniel Tomlak received many notices.  
At these pages he said:  
….there were so many alerts, warnings and advisories that crossed paths at this time….  
555 Ibid at T. 18 (after the second separator)  
556 Ibid at T. 18  
557 Exhibit 61A at T. 62  
Page: 168  
[489] As before, the recommendation was not followed. Again, not every idea, or every  
suggestion needs to be followed in order to demonstrate that any duty of care, if one is found to  
exist, has not been breached. In this case, the whole point was to have the associations, who  
would best be able to identify their members, take responsibility for informing them in what they  
took to be the best and most responsible way. This is accounted for in the direction which  
accompanied the package:  
You will find attached an advisory letter to inform practitioners of concerns which  
affect patients with alloplastic Temporomandibular Joint Implants, and of  
recommended monitoring.  
We request that you make this information available to your members via your  
journal or other mechanisms in place to disseminate information to your  
membership.558  
And in the draft letter with the salutation “Dear Doctor.” (see para. [484] above).  
[490] Lindsay Blaney recounted the work done in preparation for questions that might be asked  
of the minister following from the CBC Marketplace interview that was to, and did, take place on  
October 4, 1994.559 This included a document entitled “Background” which was not intended to  
be made public but to provide information to those to whom the expected questions could be put.  
This document had been updated. There was an earlier version dated September 20, 1994 used to  
support an earlier possible question.560 There was a second version also dated September 20,  
1994 although not associated with a particular question.561 There was an even earlier version  
dated September 16, 1994 which also appears not to be associated with any particular  
question.562 It follows that of the seven items in Lindsay Blaney’s action plan, numbers 5 and 6  
were dealt with. As already noted, as of September 29, 1994, a Canadian Import Alert was put in  
place. Thus, number 7 was also completed.  
[491] Of the seven action items this leaves only number 4: “Provide patients who have received  
a Vitek or another jaw implant with an information package.” This too was responded to and  
from the particular perspective taken, completed. Lindsay Blaney explained that a list had been  
made of patients who had themselves or through a surrogate contacted Health and Welfare  
Canada regarding TMJ implants. There were 12 of them. Consistent with the communication  
plan they were contacted through a letter:  
Dear TMJ patient  
558 Exhibit 70 at T. 18  
559 Exhibit 12 at T. 40  
560 Exhibit 71 at T. 20  
561 Ibid at T. 10  
562 Exhibit 70 at T. 19  
Page: 169  
The purpose of this letter is to inform you of concerns with alloplastic TMJ  
implants and provide you with information for proper care and monitoring. You  
will find attached documents from various sources on this issue.  
Health and Welfare Canada is aware that these implants may break apart,  
fragment, and function improperly which may cause the bone to deteriorate.  
Symptoms may vary widely, and in some cases, there may be no symptoms even  
though the implant is failing. This is why it is especially important for all patients  
with a TMJ implant to contact their implanting surgeon and or another  
maxillofacial surgeon to schedule a clinical examination and have a Magnetic  
Resonance Imaging (MRI) or CT (Computerized Tomography) if they had not  
had one within the last six months.  
Your name has been added to the TMJ Implant Recipient List for future reference  
and to keep you up-to-date on new information that becomes available to the  
Department. If you have any further concerns or need more information regarding  
this issue, do not hesitate to write to the above-mentioned address or phone the  
medical devices problems toll-free Hot-Line number 1-800-267-9675.  
Sincerely563  
[492] Included with this letter was a document, “Questions and Answers for Patients with  
Temporomandibular Implants” meant to supply additional information. There was a further letter  
sent to patients. It was dated September 7, 1995 and advised of a settlement which had been  
made in a class action in the United States. The implication was that it might be that some  
compensation for these Canadian patients was possible and was something that could be  
investigated.564 Accordingly, of the seven action items in the communications plan, number  
seven was complied with. All seven were completed.  
[493] The question raised is whether the work done, the notice, as given, and the advice  
distributed, was insufficient and represented a breach in any duty of care if one is found to have  
existed. The Plaintiff says there was such a failure. What is this assertion based on?  
[494] One possibility speaks to the relationship between Health and Welfare Canada and the  
United States Food and Drug Administration. On the one hand, were the findings of the latter  
relied on too easily by the former? Did the foundation of the decisions made by the United States  
Food and Drug Administration justify the subsequent acceptance of them, and reliance on them,  
by Health and Welfare Canada when, for example Notices of Compliance were granted to Block  
and Sheeting? On the other hand, were there situations where Health and Welfare Canada did not  
accept or act on actions proposed and undertaken by the American authorities, for example the  
decision to directly notify all doctors and surgeons? Should they have been? Is the failure to do  
so demonstrative of a failure to respond to any duty of care that could be said to exist? I observe  
what seems clear. These two perspectives stand in opposition to each other. The idea that the  
563 Ibid at T. 19  
564 Ibid at T. 21  
Page: 170  
actions of Health and Welfare Canada can be parsed such that in some cases the determinations  
of the United States Food and Drug Administration should not have been accepted when they  
were and others followed when they were not may, in some theoretical place, seem correct. In  
this situation, evolving as it did over time, the idea that the people involved at the time (as  
opposed to those with the uninhibited view of hindsight) should have seen this divergent path  
(following the FDA in some circumstances and not others) as the reasonable route to satisfying a  
possible duty of care is problematic. There is nothing intrinsically wrong with considered  
adherence to what has taken place in the United States, it just should not be blind adherence. In  
this case, having examined the Submission, and with confirmation from his superiors, Richard  
Lawuyi, sought advice from the United States Food and Drug Administration as to how they had  
proceeded. He recommended the same approach. The recommendation was accepted. When it  
came to advising all doctors, consideration was given to what was happening in the United  
States, the differences in Canada identified and a different conclusion adopted.  
[495] It should not be surprising that the Canadian representatives and their American  
counterparts were in contact and communication as the concerns for alloplastic implants, in  
general, and specifically those that utilized Proplast, developed. This is a mark of bureaucratic  
common sense. Why would we duplicate what has already been done? This is particularly so  
when consideration is given to the magnitude of the problem in the United States as compared to  
its scale here. A news release from the Department of Health and Human Services, dated  
October 2, 1991 provided an indication of the number of these implants distributed in the United  
States:  
The implants were used to treat temporomandibular joint syndrome, or TMJ, a  
painful condition of the joint that connects the jaw and the skull. At least 26,000  
implants were distributed to doctors and hospitals, but the agency does not have  
data on how many patients have them.565  
[496] It was possible that many more were implanted:  
An estimated 200,000 patients have received alloplastic TMJ implants  
nationally.566  
[497] This is to be compared to the understanding that the sole Canadian distributor  
(Instrumentarium Inc.) reported that 207 units utilizing Proplast were imported and that  
following its recall there were 162 that may have been implanted.567 For the Americans this was  
a bigger problem with broader ramifications. The United States has a larger population and, as a  
general notion, more resources to apply to its solution.  
[498] This plays a role in how the situation developed. The evidence shows that over time those  
responsible, in Canada, felt the need for and sought greater resources; more people and more  
money. The field of medical devices grew more quickly than anyone had predicted. In a  
565 Agreed Statement of Facts at footnotes 56 and 57 and Exhibit 70 at T.5  
566 Ibid at footnote 51 (Retrieval Analysis Study at p. 1)  
567 Exhibit 70 at T. 3  
Page: 171  
memorandum dated May 18, 1990 entitled “Discussion Draft-Priority Setting and Future Plans  
for Medical Devices Pre-Market Review” to E. G. LeTourneau, Director Bureau of Radiation  
and Medical Devices, W. J. Welsh Chief, Pre-Market Division, Bureau of Radiation a Medical  
Devices observed:  
As of March 1990 there were approximately 144,000 entries in the database  
representing approximately 477,000 devices offered for sale by 3,516  
manufacturers and 3,400 distributors. Approximately 25,000 devices were added  
in 1989-90. The database is a reference source for purchasers of medical devices,  
Field Operations personnel, provincial health authorities, problem reports, recalls  
etc.568  
[499] The demand for expeditious review grew with the demand for new devices. The  
manufacturers wanted to bring their products to market and health professionals and regulators  
wanted to assist those who needed treatment by allowing the sale of medical devices that would  
help relieve those patients. The memorandum referred to immediately above goes on, and under  
the heading “Inadequacies of the Present Program”, notes in part:  
The present Part V program does not provide an acceptable service to  
manufacturers. Submission processing and delays are unpredictable because of  
staff turnover and inadequate numbers of trained personnel. Over two thirds of the  
submissions are not responded to within the 60 day regulatory time limit. Because  
of the numbers of submissions and inadequate resources, in-depth scientific  
reviews often are not possible. On average, only 20-25 hours can be allocated to  
the review of a submission or package of additional information.  
The present Part V program does not provide an acceptable service to the  
Canadian consumer. Because of the inadequate resources, many high-risk devices  
and devices of unknown risk are not subject to pre-market review. Contrary to  
public belief there is no review of device notifications to monitor manufacturers  
labelling for safety and effectiveness claims. A device can be on the market for 10  
days before the Branch becomes aware of its existence. There is no regulatory  
involvement or scientific review unless there is a problem report or recall.  
Approximately 95% of the medical devices being offered for sale in Canada do  
not undergo pre-market or regulatory scrutiny.569  
[500] Beyond money and people other administrative responses were needed. One of them was  
the March 8, 1988 memo of W. J. Welsh to which I have already referred:  
568 Exhibit 49 at T. 9  
569 Ibid (The evidence of Nancy Shadeed and Dr. Richard Lawuyi makes clear that the submissions made in respect  
of Proplast products were the subject of review.)  
Page: 172  
In an attempt to speed-up the pre-market process, the following modifications are  
being implemented.570  
[501] One of the means used to expedite the process was the recognition of the usefulness of  
accepting as evidence the work that had been undertaken by the United States Food and Drug  
Administration. This was recognized in the recommendations forthcoming from a meeting of the  
Advisory Committee on Medical Devices that took place on October 25 and 26, 1988:  
Recommendation No. 5:  
The Bureau is encouraged without changing its regulations but via an internal  
working arrangement, to accept evidence of F.D.A. approval as Bureau  
acceptance of pre-market review application.  
[502] Again, this was to be considered, not blindly accepted:  
In cases of simultaneous application for pre-market review, the Bureau is to use  
its own discretion as to the procedures to follow.571  
[503] The memorandum (November 9, 1988) from W. J. Welsh A/Chief, Pre-Market Division  
to Dr. E.G. LeTourneau, Director, Bureau of Medical Devices demonstrates that this  
recommendation was followed:  
The only recommendation arising out of the October 25-26, 1988 meeting of  
relevance to the Pre-Market Division is Recommendation No. 5. As you are  
aware, we have, since last spring, been following this suggestion. Part V  
submissions for devices which have FDA PMA approval are processed with  
minimum delay.572  
[504] I point out that the process of review undertaken by Richard Lawuyi was consistent with  
this approach. He received the submissions made in support of the issuance of Notices of  
Compliance. He reviewed them as best as he could in the circumstances. In the end he felt it  
would be helpful and sought and obtained instructions to consult with the United States Food and  
Drug Administration. He recommended that the conclusion adopted there be implemented here.  
[505] Doran Ryan, the American maxillofacial surgeon, used Vitek TMJ Proplast implants  
from 1983 but stopped in 1985. He was cross-examined by counsel for the Plaintiff. He  
acknowledged his reliance on the acceptance, by the United States Food and Drug  
Administration, of Vitek Proplast TMJ implants for use in treating patients. He did this  
understanding that the approval was based on a submission made pursuant to the 510K process.  
570 Exhibit 12 T. 31  
571 Exhibit 49 at T. 31 and para 239 a bove  
572 Ibid at T. 4  
Page: 173  
Under this approach the manufacturer could obtain entry to the market by demonstrating that the  
“new device” was “substantially equivalent” to one already being used. There was no reliance,  
by the regulator, on studies demonstrating the “safety and efficacy” of the product. It was  
suggested that this was not, at the time, a regulatory requirement in the United States.  
Q. Okay. And so, the predicate device, as I understand it, maybe have preceded a  
point in time at which the FDA was even in the business of reviewing safety and  
efficacy?  
A. It could be. I don't know that. I don't know.573  
[506] The implication was that, in the absence of evidence of safety and efficacy, the Canadian  
regulators had erred in relying on the American authorization. I do not accept this assertion. It  
seems self-evident that the foundation behind the 510K approach used by the United States Food  
and Drug Administration is that the safety and efficacy are sufficiently demonstrated by the  
presence in the market of the product that is “substantially equivalent” to the devices for which  
access to that market is being sought. Why do more tests when the required result has already  
been demonstrated by the acceptance and use of a similar product? In this case, it was based on  
the use of “silastic implants” in joints other than the jaw:  
I think they went on the history of the silicone implants in other joints, using  
fingers and other places. It was used to prevent joints from healing together  
causing ankylosis. That's what I understood about the silicone implants and what  
the FDA's thought was on the use of silicone implants. Other than that I don’t  
know what their standard was in determining whether a product was safe.574  
[507] Doran Ryan agreed that in an acceptance, as provided by the United States Food and  
Drug Administration, there is a measure of risk. Counsel for OHIP, in questioning Doran Ryan  
wondered whether or not the United States Food and Drug Administration would have  
undertaken a risk assessment.575 I do not believe it is outside the proper application in my role to  
note it is difficult if not impossible to objectively assess risk of the unknown, for example: the  
body’s response to a new treatment. I repeat we are balancing efficacy (our desire to help those  
in pain) against safety (will we harm rather than help them). Whether where any particular  
medical device may fall between these two ends leaves it as appropriate for the issuance of a  
Notice of Compliance is a matter of discretion for the responsible regulator. It may be that there  
is something that can be learned from the experience with earlier and other efforts. That is the  
proposition behind the form 510K approach.  
573 Transcript: Cross-Examination of Doran Ryan (June 4, 2019) at p. 5 (Later in his examination I proposed to  
counsel for the plaintiff that Doran Ryan had said that at the time there was no requirement for the United States  
Food and Drug Administration to look at safety and efficacy. Counsel agreed (see: p. 12). It would seem we were  
both wrong.)  
574 Ibid at p. 7  
575 Ibid at pp. 7-8  
Page: 174  
[508] In Canada there is a similar but not identical process. This was “grandfathering”, to  
which I have already referred. This encompassed the idea that if a medical device was sold in  
Canada prior to the regulatory amendments made effective on April 1, 1983 its sale and use  
would be allowed to continue. There was evidence to show that those supporting the utilization  
of Vitek Proplast devices claimed that such sales had taken place and that they should be  
recognized as “grandfathered”. This was not accepted in either 1987 or 1988. The submissions  
made were based on the understanding that the post-1983 regulatory scheme applied. Within the  
trial the Crown acknowledged that no reliance was being placed on any supposed prior sales and  
that the idea of “grandfathering” was not available as a means of exculpating it (the Crown) from  
any failure to follow the requirements of the post-1983 regulatory scheme, in particular the need  
to be satisfied of the “safety and efficacy” of the device in issue.  
[509] The issue remains whether there was a breach of this requirement evidenced by the  
acceptance of advice from the United States Food and Drug Administration in circumstances  
where its acceptance of Vitek Proplast products was based on a 510K submission. The fact  
remains that the medical devices, brought forward by Vitek Inc., that were dedicated TMJ  
implants (Proplast TMJ Interpositional Implants, Proplast TMJ Condylar Prosthesis, Type VK  
and Proplast TMJ Fossa Prosthesis, Type VK) were not granted Notices of Compliance. It is  
only “Block and Sheeting” that were recognized in this way. I repeat my determination that this  
was not an authorization that foresaw the use of Block and Sheeting as TMJ implants. It did not  
accept those “devices” for this kind of orthopaedic use.  
[510] Even so I should point out that Doran Ryan was asked whether further studies should  
have been done. In particular he was asked whether the United States Food and Drug  
Administration “should have done a safety assessment before allowing Proplast-Teflon be  
implanted into the jaw”.576 The question presupposes that it was the regulatory scheme active in  
the United States that made it the responsibility of the regulator (the United States Food and  
Drug Administration) to undertake these studies. There is nothing to suggest this was the case.  
Moreover, there is no indication what a “safety assessment” would be. For myself, I find it  
difficult to distinguish the concept of a “safety assessment” from a “risk assessment” as  
discussed above. The regulation requires a balancing of “safety” against “efficacy”, not the  
treatment of safety as a single consideration. The answer of Doran Ryan to the question that was  
asked is apropos:  
I think that they should have, and Proplast Teflon should have had better studies  
to show that it was safe and effective. I'm not sure it's the FDA's position to do  
those studies. They rely on the companies to provide those studies so that they  
can evaluate. I think they probably could have used some more evaluation from  
Vitek before they approved that product.577  
[511] Doran Ryan went on to acknowledge that there were studies that had been done by Vitek:  
576 Ibid at p. 9  
577 Ibid at pp. 9-10  
Page: 175  
Q. And, Dr. Ryan, you are generally familiar with the studies that were done by  
1983 on Vitek Proplast TMJ?  
A. Generally. I know they did some bench studies on the joint, and they looked  
at wear particles that were produced, and the amount of wear particles based on  
that assumption that 20 pounds of pressure on a joint at any given time. I was  
aware that they had done some bench studies on the product at Vitek.578  
[512] Doran Ryan summarized the basis for his acceptance and use of Vitek Proplast as a  
suitable component of TMJ implants:  
Q. Okay. Sorry, Your Honour. I'll start again. Is it fair to say that the bench  
testing wouldn't satisfy you as to safety or efficacy; correct?  
A. At the time that I implanted, I was satisfied with the testing, relying on the  
FDA. Also, that they approved the product, and the nine-year history they had  
with it. I'm not a scientist. I'm a surgeon.579  
[513] The reference to a nine-year history is a citing of the Kiersch study which I have already  
noted (see paras. [156-157] above).580  
[514] It is not for me to look behind the work done by the United States Food and Drug  
Administration in allowing for the sale and use of Vitek Proplast products. It is whether the  
taking note of that conclusion and any consequential reliance on it by Health and Welfare  
Canada was reasonable or, to the contrary, was demonstrative of a failure of any duty of care if  
one is found to exist. In the circumstances I find that to the extent of it, any reliance placed on  
the treatment of the Vitek TMJ Proplast implants by the United States Food and Drug  
Administration was appropriate. In recommending that Block and Sheeting be given Notices of  
Compliance and that inter-positional implants, TMJ Fossa Prosthesis, Type VK and TMJ  
Condylar Prosthesis, Type VK not be, Richard Lawuyi did more than just telephone the United  
States Food and Drug Administration and then do what it had done.  
[515] This takes me to the other side of the equation: the proposition that there were actions  
undertaken by the United States Food and Drug Administration that were not replicated by the  
Canadian authorities when they should have been and that the failure to do so was a breach of the  
duty of care if one is found to exist. For the most part this assertion refers to (1) the recognition  
that the concerns raised were not just with respect to interpositional implants but to all Proplast  
products including Proplast TMJ Condylar Prosthesis, Type VK and Proplast TMJ Fossa  
Prosthesis, Type VK, and (2) the various suggestions made by the United States Food and Drug  
578 Ibid at p. 10  
579 Ibid at p. 11  
580 For ease I repeat the citation for the study done by Kiersch: “Kiersch TA. The use of Proplast-Teflon implants for  
meniscectomy and disc repair in the temporomandibular joint [Abstract]. Presented at the AAOMS Clinical  
Congress on Reconstruction with Biomaterials, San Diego, 1984”.  
Page: 176  
Administration that efforts be made to notify all physicians and dentists who had purchased or  
implanted Vitek TMJ Proplast implants. Both occurred after:  
the March 23, 1990 Voluntary Safety Alert issued by Vitek, Inc. which included a  
request that all unused implants be returned for a credit  
the December 28, 1990 FDA Safety Alert, and  
the recall of January 7, 1991 by the United States Food and Drug Administration.  
[516] The first two of these were directed to the physicians (“Dear Doctor”, “To Oral and  
Maxillofacial Surgeons”). The third was announced by way of a news release dated January 8,  
1991 which advised of the recall and the concerns related to the Vitek products. It gives no  
direction as to who was to be notified.  
[517] It identifies the products first, as “certain jaw implants” but subsequently as:  
The devices known as interpositional implants, were manufactured by Vitek, Inc.  
of Houston Texas.  
And  
About 26,000 of the Vitek interpositional implants were distributed. It is not  
known how many were implanted in patients. 581  
[518] Having learned of the firm-initiated recall on May 16, 1990, Health and Welfare Canada,  
the next day, sent the “Information of Potential Recall” to the Medical Devices Unit in the  
Central Region. By August 3, 1990 Health and Welfare Canada was aware that four doctors had  
received the implants and on August 20, 1990 the Instrumentarium Inc. recall was initiated.  
Consistent with the approach in the United States the instructions to “All Instrumentarium  
Agents” was to “make sure that every physician having used these items are made aware of this  
situation”. The recall suggested that “you leave a copy of the notification letter behind with each  
of the physicians involved.”582 Similarly, in Canada, the substance of the recall was in keeping  
with the action taken in the United States. The August 20, 1990 recall was a “voluntary recall”  
instituted not by the manufacturer, Vitek, Inc. but by the distributor, Instrumentarium Inc. Any  
apparent delay was caused by the fact that for whatever reason, Instrumentarium Inc. had not  
been made aware, by Vitek, Inc. of its recall in the United States. This was recognized in the  
letter signed by Francine Jacques (Gaudette), as Inspector, Medical Devices Unit on August 23,  
1990 to Richard Vincent, CEO, of Instrumentarium Inc:  
Dear Mr. Vincent:  
581 Exhibit 70 at T. 5 and at T. 11D  
582 Agreed Statement of Facts at para. 116 and the footnoted documents including Exhibit 70 at T. 11B  
Page: 177  
This letter is to follow up on our visit of August 21, 1990, regarding the recall of  
all lots of Vitek temporomandibular joint (TMJ) interpositional implants (IPIs).  
The catalogue numbers involved in Canada are 912.71, 912.72 and 912.74.  
It appears that you had not received the communication from Vitek and that we  
informed you of this recall during our telephone call on August 16, 1990…  
[519] In Canada, insofar as notifications were concerned, Instrumentarium Inc. directed its  
agents to contact the “physicians” involved. It is not accurate to suggest that the Canadian  
authorities did not demonstrate an interest in the broader range of Vitek TMJ Proplast products.  
The letter to Richard Vincent of August 23, 1990 (three days after the Canadian voluntary recall  
was initiated) notes:  
Section 34 of the Medical Devices Regulations allows the sale of a new device  
only if the manufacturer of the product has received a notice of compliance.  
Therefore, during our visit, you agreed to the voluntary detention of all Vitek and  
Novamed Proplast implants for which a notice of compliance had not been  
issued.583  
[520] The letter then lists the Catalogue No.’s, the Quantity (Units) and Value ($) of the  
products that were detained. The list includes Catalogue No’s: 813.16 and 813.17 (both examples  
of Proplast HA/UPE TMJ Fossa Prosthesis, Type VK’s), as well as, 813.61, 813.67 and 813.68  
(each an example of Proplast HA TMJ Condylar Prosthesis, Type VK’s). This stands as an  
example of Health and Welfare Canada looking beyond the actions in the United States. This  
occurred in the context of the recall commenced on August 20, 1990 and follows on from one of  
the inspections undertaken by Francine Jacques (Gaudette).  
[521] The notice that followed was the republication of the March 23, 1990 Vitek, Inc.  
Voluntary Safety Alert which appeared in the Canadian Dental Association Journal584 (April  
1991 Vol. 57 No. 4). It was introduced by a letter published on the preceding page of the journal:  
The Health Protection Branch (HPB) wishes to ensure that every dental surgeon  
concerned is made aware of the following Voluntary Safety Alert issued by Vitek  
Inc. in 1990.  
In Canada, the Vitek Temporomandibular Joint (TMJ) and Interpositional Implant  
(IPI) were imported and distributed by Instrumentarium….  
[Emphasis by underlining and italics added]  
583 Ibid at para. 117 and at Exhibit 61A T.24) as well as Exhibit 59 T. 49 (English translation)  
584 Exhibit 70 T. 10  
Page: 178  
[522] The presence of “Vitek Temporomandibular Joint” separate from the identification of  
“Interpositional Implant” but joined by the conjunction “and” suggests a concern for more than  
just “interpositional implants”. The reference to “Vitek temporomandibular joint” demonstrates a  
broader concern that extends to other Vitek products. This extension is recognized in the further  
republication, this one of the FDA Safety Alert dated December 28, 1990. It appeared in the  
Canadian Dental Association Journal585 (April 1991 Vol. 57 No. 8) and was introduced as  
follows:  
Health Protection Branch Issues Second Alert  
The Operations of Compliance Division of the Health Protection Branch, Health  
and Welfare Canada, has issued a second alert-the first was published in the April  
1991 issue of the CDA Journal-regarding the Vitek Temporomandibular Joint and  
Interpositional Implants….  
[Emphasis by underlining and italics added]  
[523] This is the same wording and separation of concerns, the first for “Vitek  
Temporomandibular Joint” Implants and the second for “Interpositional Implants”. That this  
concerns separate product types of implants is underscored by what the introduction says after it  
identifies the manufacturer and distributor of those products:  
Both have been associated with fragmentation and/or a foreign body response.  
[Emphasis added]  
[524] This continues the Canadian interest in products beyond Interpositional Implants at a time  
before this concern was expressed by American authorities.  
[525] The third republication, this one in the November 1991 issue of the Canadian Association  
of Oral and Maxillofacial Surgeons Newsletter586 is ambiguous. The letter being published was  
authored in Canada, not in the United States. It refers only to “Interpositional Implants” as the  
heading but uses broader language in the succeeding substantive sentence:  
Interpositional Implants  
The legacy of the Vitek temporomandibular joint prosthesis continues, although  
the company and the product are no longer around…  
[Emphais added]  
585 Ibid  
586 Ibid  
Page: 179  
[526] As we have seen the term “Interpositional Implants” may refer to a specific type of  
prosthesis but is also used in a generic fashion attributable to all devices used to replace or  
augment the meniscus between the fossa and the condyle.  
[527] In the period following the recalls, the United States Food and Drug Administration  
began to show interest and concern for Vitek Proplast products beyond TMJ implants. The  
Public Health Advisories issued by the United States Food and Drug Administration during  
September 1991 addressed the broader array of Vitek TMJ Proplast implants and sought to have  
the patients who had received them identified, examined and monitored. The Agreed Statement  
of Facts notes that the article which appeared in the “Medical Devices Bulletin” during October  
1991, made the statement that on October 2, 1991 patients with Vitek TMJ Interpositional  
Implants had been advised, by the United States Food and Drug Administration, to be examined  
and monitored. The Medical Devices Bulletin says exactly that:  
On October 2, FDA advised patients with certain jaw implants manufactured by  
Vitek, Inc. of Houston to be reevaluated by their oral and maxillofacial surgeons  
or dentists to determine whether the implants are breaking down or causing bone  
degeneration.  
[528] It also says that the United States Food and Drug Administration was taking  
responsibility for notifying these patients:  
FDA is taking responsibility for alerting patients, since Vitek, Inc., which was  
ordered to notify oral and maxillofacial surgeons, is bankrupt. The devices were  
manufactured by Vitek from 1973 through 1988.  
[529] And that in furtherance of taking on this responsibility the United States Food and Drug  
Administration was establishing a program to undertake this notification:  
FDA is establishing a notification program for patients with the Vitek implant,  
which will be operated by Medic Alert, a nonprofit foundation. Oral and  
maxillofacial surgeons who have implanted the devices, dentists treating patients  
with the devices, or patients who have the implants are urged to call 800-554-  
5297 for further information.587  
[530] What the Medical Devices Bureau does not explain is what was done on October 2, 1991  
to “advise patients…to be reevaluated.” It appears to be nothing more than issuing the “Medical  
Alert”588 and issuing a press release589 on that day. There is nothing that directs or purports to  
deliver either of these documents to patients. The latter is “For Immediate Release” but does not  
say to who. It states what is repeated in the Medical Alert Bulletin; that the “Food and Drug  
Administration today advised patients with certain jaw implants…to obtain an immediate  
examination” and that it was “taking responsibility for alerting patients.” Presumably, it is  
587 Agreed Statement of Facts at para. 70  
588 Ibid at para. 71  
589 Ibid at para. 71  
Page: 180  
referring to the former document (the Medical Alert) but while this document is entitled FDA  
Notifies Physicians and Patients About Risks of TMJ Implants and while it indicates that a toll-  
free number had been established to advise health professionals and patients about risks  
associated with temporomandibular join implants manufactured by Vitek Inc., there is nothing  
that explains how this had been, or how it was to be, brought to the attention of the patients.  
[531] The difficulty in doing this was noted in the press release:  
At least 26,000 implants were distributed to doctors and hospitals but the agency  
does not have data on how many patients have them.  
[532] I review this because in comparing the response of Health and Welfare Canada to the  
concerns and actions of the United States Food and Drug Administration, it is important to  
understand what the American regulators did with respect to their increased concern for the  
broader range of products and the patients involved. By the end of October, 1991, it had done  
nothing beyond issuing Public Health Advisories, publishing an article in its Medical Devices  
Bulletin, issuing a Medical Alert and an accompanying press release. No direct action was taken  
to identify or get in touch with patients. All that followed in the United States during the  
succeeding years were more Bulletins (December 1, 1991), Alerts (May 29, 1992, Advisories  
(August 1992/redistributed July 1993) and articles (October 1993 based on a workshop that had  
taken place in November 1992). Finally, there was the letter of July 15, 1994 to: “Orthopedic  
Surgeons, Otolaryngologists, Plastic and Reconstructive Surgeons and the letter of September  
24, 1994 from the American authorities to, among others, Dr. Richard S. Tobin. The Canadian  
response was in line with and similar to that of the United States. An Import Alert was issued,  
the seven point communication plan was prepared and acted on, including the preparation of a  
letter to be sent to six professional associations whose members would be aware of patients who  
had received these implants, a package to be delivered to the patients who had or would be  
identified, as well as media messaging from politicians and bureaucrats.  
[533] In cross-examination Lindsay Blaney was asked how it could be that the Canadian  
response had not been stronger and more vociferous. There were suggestions that it should have  
been but these were rejected by those responsible. Lindsay Blaney was careful to explain how  
the Canadian situation was different from that of the United States. There it was understood that  
26,000 of the implants of concern had been distributed. There was no certainty as to how many  
had been implanted and no way of identifying exactly who the recipients were. It was understood  
that the American recall had not been a success590 whereas the one in Canada was complete.591  
Only 162 of the implants had been identified as having been used in Canada.  
590 Exhibit 49 at T. 11, Exhibit 59 at T. 42 (Memorandum dated August 3, 1990 R. W. Scales A/Medical Device  
Specialist to Benoit Toupin Supervisor):  
Follow-up with the FDA in Dallas on August 2 indicated that the manufacturer, Vitek Inc., had  
filed for bankruptcy and was in receivership. Their investigation is continuing into the matter  
due to possible inadequacy of the recall.  
Page: 181  
[534] In the circumstances, whether it be the acceptance of the advice provided by those at the  
United States Food and Drug Administration or the supposed failure to respond to that advice in  
an appropriate manner, I am unprepared to accept that the use of and adherence to that advice by  
the officials at Health and Welfare Canada was anything other than considered, appropriate and  
reasonable in the circumstances and certainly not demonstrative of any breach of any duty of  
care, if one is found to exist, as between the Crown and the members of the class.  
[535] To my mind it seems clear that interaction between the responsible individuals and  
agencies in different countries and jurisdictions is advisable and should be beneficial. There is  
evidence that co-operation is active in the field of Medical Devices:  
The 1988 version of the program for “Inspection of Manufacturers, Importers and  
Distributors of Medical Devices” includes an encouragement to Canadian  
industry to use the United States Food and Drug Administration approach and  
Guidelines in addressing good manufacturing practices.592  
There is an international registry of patients involved with these implantable  
devices.593  
On May 28, 1991 there was the tripartite meeting involving representatives from  
the United States Food and Drug Administration, Health and Welfare Canada and  
the United Kingdom’s Department of Health and Social Security.594  
On October 28, 1991, the United States Food and Drug Administration informed  
foreign regulatory agencies of Vitek TMJ IPI device sales within their countries  
and remedial measures that the United States Food and Drug Administration had  
taken.595  
The letter of September 14, 1994 sent by George A. Brubaker, Acting Director,  
Office of Standards and Regulations, Center for Devices and Radiological Health  
to “Dear Colleague” in this case being Richard S. Tobin.596  
591 Agreed Statement of Facts at paras. 117, 118 and 119  
592 Exhibit 59 at T. 38  
593 Agreed Statement of Facts at para. 73:  
The Medical Bulletin issued on December 1, 1991 provided information on how to enroll in the  
international patient registry.  
594 Agreed Statement of Facts at para. 67  
595 Agreed Statement of Facts at para. 72  
596 Exhibit 70 at T. 15  
Page: 182  
[536] The interaction between the United States Food and Drug Administration and Health and  
Welfare Canada was demonstrative of this interrelationship and, so far as I can see, was a benefit  
to all. The efforts of Health and Welfare Canada are more than enough to respond to the narrow  
assertion of Doran Ryan referred to in the Submissions of the Plaintiff that it was important to  
inform all patients that the implants they had received had been recalled.597  
ANALYSIS  
[537] I return to what was said at the beginning of these reasons. The search for the balance  
between private and public responsibility is a difficult one. It has been the subject of some  
relatively recent consideration. This case is founded in negligence. The common issues that arise  
from its certification as a class action are tied to the tests that consider whether negligence is  
proved. The law talks in terms of the presence of a “private” duty of care. The courts are used to  
applying the approach that originates in the case of Anns v. Merton London Borough Council.598  
That case has been set aside in the United Kingdom but continues to be relied on in Canada,  
adopted and adapted by cases like Cooper v. Hobart599 and Kamloops (City of) v. Nielsen.600 The  
Submissions of the Plaintiff and the Submissions of the Defendant both make brief reference to  
Paradis Honey Ltd. v. Canada (Attorney General).601 In the Submissions of the Plaintiff the  
reference is in only one paragraph. In the Submissions of the Defendant it is a reference in a  
footnote.602 That case recognizes the broad distinction between how private and public activity is  
treated by the common law:  
…By and large, our common law recognizes the differences between private and  
public spheres and applies different rules to them. Private matters are governed by  
private law and are addressed by private law remedies; public matters are  
governed by public law and are addressed by public law remedies. This has  
become a fundamental organizing principle: Dunsmuir, above; Canada (Attorney  
General) v. Mavi, 2011 SCC 30 (CanLII), [2011] 2 S.C.R. 504; Air  
Canada v. Toronto Port Authority, 2011 FCA 347 (CanLII); [2013] 3 F.C. 605.603  
[538] The case proposes that the private law (negligence) is not the only way, perhaps not the  
preferable means, to assess any tort or fault alleged against a public official or agency acting in  
the name of the Crown:  
At the root of the existing approach is something that makes no sense. In cases  
involving public authorities, we have been using an analytical framework built for  
private parties, not public authorities. We have been using private law tools to  
597 Submissions of the Plaintiff at paras. 46 and 50  
598 [1977] UKHL 4, [1978] AC 728  
599 2001 SCC 79 (CanLII), [2001] 3 SCR 537, [2001] SCJ No 76 (QL), [2001] CarswellBC 2502, 206 DLR (4th)  
193, [2002] 1 WWR 221, 261 WAC 268, 96 BCLR (3d) 36  
600 1984 CanLII 21 (SCC), [1984] 2 SCR 2, [1984] CarswellBC 476, [1984] SCJ No 29 (QL), 54 NR 1, 10 DLR  
(4th) 641, [1984] 5 WWR 1, 66 BCLR 273, 11 Admin LR 1, 29 CCLT 97  
601 2015 FCA 89 (CanLII), [2016] 1 FCR 446, [2015] FCJ No 399 (QL), 382 DLR (4th) 720  
602 Respectively paragraph 484 and footnote 477  
603 Paradis Honey Ltd. v. Canada (Attorney General), supra (fn. 601) at para. 129  
Page: 183  
solve public law problems. So to speak, we have been using a screwdriver to turn  
a bolt.604  
[539] The decision of the majority suggests that it is time for public law principles to be applied  
and where appropriate used as the foundation for monetary damages. On the one hand: “A claim  
for monetary relief in public law is novel”605 On the other hand “Nothing obstructs this. In  
particular, the traditional rules of Crown immunity and the Crown Liability and Proceedings  
Act606 and its predecessors have not prevented the granting of monetary relief in public law  
cases…”607  
[540] The tool offered by public law is judicial review. When the action of the Crown is outside  
the boundaries of what the authorities dictate, the court will proceed to move to the question of  
remediation, the remedy. In an application for judicial review remedies are discretionary:  
This framework the unacceptability or indefensibility in the administrative law  
sense of the public authority’s conduct and the court’s exercise of remedial  
discretion should govern whether monetary relief in public law may be had by  
way of action.608  
[541] While Paradis Honey proposes a different approach; it is not much help here. The  
decision reflects on a motion to strike the Statement of Claim as disclosing no reasonable cause  
of action. The conclusion was that it was not plain and obvious that the action could not succeed.  
The final decision on whether the plaintiff would succeed awaited trial. In the case before this  
court we have had the trial. The evidence demonstrates that the understanding of the impact of  
Proplast on the condition of those who received the implants evolved over time. The decision of  
whether a product was to be granted a Notice of Compliance contains a large measure of  
discretion. (Where did the product fall in the balance between safety and efficacy?) None of the  
devices directed specifically for use as temporomandibular joint implants were issued Notices of  
Compliance. Only those intended for a broader, more general intended usage were taken to have  
established a balance that supported granting the permission to enter the market. It was still for  
604 Paradis Honey Ltd. v. Canada (Attorney General), supra (fn. 601) at para. 127  
605 Paradis Honey Ltd. v. Canada (Attorney General), supra (fn. 601) at para. 116  
606 R.S.C. 1985, c. C-50  
607 Paradis Honey Ltd. v. Canada (Attorney General), supra (fn. 601) at para. 140 citing Roncarelli v. Duplessis  
[1959] S.C.R. 121, 16 D.L.R. (2d) 689 and McGillivray v. Kimber (1915), 1915 CanLII 608 (SCC), 52 S.C.R.  
146, 26 D.L.R. 164 and at para. 131:  
In McGillivray v. Kimber (1915), 1915 CanLII 608 (SCC), 52 S.C.R. 146, 26 D.L.R. 164, the  
Supreme Court granted monetary relief and, in so doing, did not invoke negligence principles or  
any other nominate cause of action in private law. And in Roncarelli, above, the Supreme Court  
(per Justice Rand at page 142) granted monetary relief, relying not only on negligence  
(then article 1053 of the Civil Code of Québec) but also on “the principles of the underlying  
public law.”  
608 Paradis Honey Ltd. v. Canada (Attorney General), supra (fn. 601) at para. 127 at para. 139  
Page: 184  
the surgeon to decide if or how to use them. Once the difficulties were discovered, there were  
inspections and a wide set of notices distributed.  
[542] As it is the Plaintiff does not seek monetary damages through reliance on public law  
principles:  
In the unique facts of this case, a public law remedy would be appropriate. What  
the plaintiff class is seeking is a mandatory order compelling the Ministry of  
Health to correct the record, and to inform Canadians that certain Proplast devices  
had been approved by Health Canada, were likely implanted into a number of  
Canadians, and had never been recalled by Health Canada.609  
[543] This request does not comport with the evidence as I have understood it. Much effort was  
made to inform Canadians. Those efforts have been undertaken considering the situation as it  
developed, keeping in mind the Canadian circumstances. There is little, if any, evidence to  
suggest that there were any relevant health professionals who did not receive notice. A remedy at  
public law is discretionary. Surely, that discretion requires some consideration of the purpose  
and utility of the proposed relief. In this case the Court is being asked to compel notice in respect  
of devices that were either not granted Notices of Compliance or, where Notices of Compliance  
were issued despite the fact that there is not a demonstrated case of any of those devices (Block  
or Sheeting) having been used as temporomandibular joint implants. No surgeries implanting any  
of these devices (including those not issued Notices of Compliance) took place after 1990, at  
which time the products were removed from the market. The size of the class was recognized by  
the Superior Court as long ago as 2007 as likely being smaller than the 2,600 suggested by the  
Plaintiff (“the class might not exceed 200 persons”).610 The only justification for the higher  
number was its relationship to the stated number of these implants used in the United States. The  
Court of Appeal in 2012 came to the conclusion that the class was “a relatively small group of  
consumers.611 If I were required to, I would exercise my discretion against such a remedy.  
There is little to be gained from a notice this long after the events that led to this litigation. There  
is no “record to correct”.  
[544] As it is, the discretionary nature of the decisions made, dictate against any finding that  
the defendant acted outside its authority:  
Indeed, where a decision is thoroughly suffused by facts, policies, discretions,  
subjective appreciations and expertise, the margin of appreciation may be so wide  
that, absent bad faith, it is hard to see how the remedial stage could ever be  
reached.612  
609 Submissions of the Plaintiff at para. 486  
610 Taylor v. Canada (Health), supra (fn. 17) at para. 60  
611 Taylor v. Canada (Attorney General), supra (fn. 35) at para. 111  
612 Paradis Honey Ltd. v. Canada (Attorney General), supra (fn. 601) at paras. 127 and137  
Page: 185  
[545] This case does not reach the point where the remedial stage would need to be  
considered.613  
[546] This leaves the Court to consider this case as founded in negligence. This too has been  
the subject of some consternation, thought and inquiry. In an article entitled “Before Kamloops:  
The Canadian Law of Public Authority Liability That Might Have Been”614 the author posits that  
the Canadian treatment of the issue has been sidetracked. He begins by noting that there are two  
general approaches to liability in negligence of public authorities:  
First, there is the Diceyan approach, under which public authorities can owe a  
duty of care only in situations where a similarly situated private person would  
owe a duty of care. Second, there is the approach under which unique duties of  
care, duties which have no application as between private persons, are imposed on  
public authorities.  
[547] The author proposes that, to our collective detriment, with the appearance of Anns v.  
Merton London Borough Council and its adoption in Kamloops v. (City) v. Nielsen, Canada  
began an experiment into imposing broader duties of care in negligence law in general and on  
public authorities in particular. We have taken up the second approach. The article suggests that  
our allegiance to Anns “…belies inconsistent adherence”:  
But despite three decades of inventing, adopting, modifying, or ignoring various  
legal concepts and tests for public authority liability, the official orthodoxy  
supposes an unbroken continuity of legal doctrine from Anns to the present. The  
claim cannot be reconciled to the outcomes in individual cases.  
[548] The article wonders about what the author sees as a return to an earlier, if “nascent”,  
approach founded on the application of Hedley Byrne v. Heller615 to public authorities. This  
requires a broader understanding of the principle in that case than is typically described:  
The underlying principle [of Hedley Byrne] rested on an assumption of  
responsibility by the defendant towards the plaintiff, coupled with a reliance by  
the plaintiff on the exercise by the defendant of due skill and care. The principle  
that a duty of care could arise in that way was not limited to a case concerned  
with the giving of information or advice (the Hedley Byrne case) but could  
include the performance of other services.616  
613 Well known cases where public officials acted outside their authority (for an improper purpose and referenced in  
Paradis Honey at para. 86 are Re Multi-Malls Inc. and Minister of Transportation and Communications (1977),  
1976 CanLII 623 (ON CA), 14 O.R. (2d) 49, 73 D.L.R. (3d) 18 (C.A.), where the Minister of Transportation refused  
access permits to the adjacent highway for “planning reasons”; Doctors Hospital v. Minister of Health et  
al. (1976), 1976 CanLII 739 (ON SC), 12 O.R. (2d) 164, 68 D.L.R. (3d) 220 (Div. Ct.) where it was proposed to  
close the hospital for economic reasons which was beyond the authority given in the applicable regulation.  
614 de Vries, Jonathan; Supreme Court Law Review (2019) 93 S.C.L.R. (2d) 117  
615 (1964) AC 465 (HL)  
616 Michael v. Chief Constable of South Wales Police, [2015] A.C. 1732 at para. 67 (U.K. S.C.)  
Page: 186  
[549] The author of the article describes the result: “Under its broader interpretation the  
principle of Hedley Byrne extends to any situation in which a defendant has interfered, whether  
by a representation or some other reliance-inducing action, in the autonomous choices of a  
plaintiff, resulting in a loss that the plaintiff would not have otherwise suffered.” The article  
considers the work of G.H.L. Fridman in assessing the post-Hedley Byrne law of public liability  
and concludes that it was (and presumably still could be) possible for negligence law to deal with  
issues of government action that caused harm to private citizens within the law of obligations,  
and without the need to carve out special duties, tests and immunities for public actors. Needless  
to say, no submissions were made on this account. I mention it only to demonstrate the breadth  
of the consideration being brought to bear on the issue.  
[550] The submissions of both sides consider the case to be decided by the Court from the  
perspective of the approach and tests set out by Anns v. Merton London Borough Council.  
Application of those tests answers the first of the common issues set in this case: Did Canada  
owe a duty of care to class members?” I alluded to that test earlier in these reasons. The two  
stage approach the test represents is summarized in Edwards v. Law Society of Upper Canada:  
At the first stage of the Anns test, the question is whether the circumstances  
disclose reasonably foreseeable harm and proximity sufficient to establish a prima  
facie duty of care. The focus at this stage is on factors arising from the  
relationship between the plaintiff and the defendant, including broad  
considerations of policy. The starting point for this analysis is to determine  
whether there are analogous categories of cases in which proximity has previously  
been recognized. If no such cases exist, the question then becomes whether a new  
duty of care should be recognized in the circumstances. Mere foreseeability is not  
enough to establish a prima facie duty of care. The plaintiff must also show  
proximity that the defendant was in a close and direct relationship to him or  
her such that it is just to impose a duty of care in the circumstances. ...  
If the plaintiff is successful at the first stage of Anns such that a prima facie duty  
of care has been established (despite the fact that the proposed duty does not fall  
within an already recognized category of recovery), the second stage of the Anns  
test must be addressed. That question is whether there exist residual policy  
considerations which justify denying liability. Residual policy considerations  
include, among other things, the effect of recognizing that duty of care on other  
legal obligations, its impact on the legal system and, in a less precise but  
important consideration, the effect of imposing liability on society in general.617  
[551] In Attis v. Canada (Health) the Court of Appeal found that it was reasonably foreseeable  
618  
that unsafe medical devices could cause harm to consumers.  
The Crown does not contest  
foreseeability in this case.619  
617 2001 SCC 80, [2001] 3 S.C.R. 562 (S.C.C.), at paras. 9-10 quoted in Taylor v. Canada (Attorney General), supra  
(fn. 35) at para. 72.  
618 Supra (fn. 22) at para. 52  
Page: 187  
[552] This takes these reasons to the issue of proximity. The Submissions of the Plaintiff  
contend that there are analogous cases in which proximity has previously been recognized.  
Particular reliance is placed on Fullowka v. Pinkerton’s of Canada Ltd.620 This proposition has  
already been dealt with by the Court of Appeal. It considered this question as part of the special  
case heard by the five-judge panel in 2012 in respect of the certification of this case:  
No prior case is a perfect fit for this one, otherwise there would be no need to redo  
the proximity analysis. In Fullowka, the regulator was physically present in the  
mine on several occasions and was required by statute to directly regulate the  
conduct of the miners. Those features, which do not exist in this case, render the  
relationship between the regulator and the miners in Fullowka closer than the  
relationship between Health Canada and the recipients of the implants.621  
[553] The Court went on to consider the possibility of an analogous determination by reference  
to a second case, Doe v. Metropolitan Toronto (Municipality) Commissioners of Police:622  
Similarly, in Doe, the police were aware that the plaintiff was one of a handful of  
persons who had potentially been targeted by a serial rapist. The police were also  
under a specific statutory duty to prevent crime. That degree of specificity is not  
present on the facts as alleged in this case.623  
[554] In the Submissions of the Plaintiff, counsel for the Plaintiff and the Ontario Health  
Insurance Plan (“OHIP”) also rely on Brewer Bros. v. Canada624 as a case dealing with an  
analogous situation rendering any specific analysis as to the presence of proximity unnecessary.  
It is not and it does not. The case does not deal with proximity. The duty discussed sprung from  
the statute. In Brewer the Federal Court of Appeal upheld a decision finding that a duty of care  
was owed by the Canadian Grain Commission to grain producers who sold their grain to a grain  
elevator operator licensed by the Commission. The Commission was found to owe a duty of care  
to take proactive steps to protect the producer from financial losses occasioned by the bankruptcy  
of the licensed operator. The Court examined the legislation and determined that:  
The statute provides strong evidence of a private law duty of care.625  
[555] What is now Health Canada owes its statutory responsibilities to the “public at large”.  
This was acknowledged by the Submissions of the Plaintiff.626 This is directly opposite to  
Brewer Bros., where the duty was found to be owed to a “defined group”:  
619 Submissions of the Defendant at para. 272  
620 [2010] 1 S.C.R. 132, [2010] S.C.J. No. 5, 2010 SCC 5 (CanLII),  
621 Taylor v. Canada (Attorney General), supra (fn. 35) at para. 112  
622 74 OR (2d) 225, [1990] OJ No 1584 (QL),72 DLR (4th) 580, 40 OAC 161  
623 Taylor v. Canada (Attorney General), supra (fn. 35) at para. 113  
624 1991 CanLII 8184 (FCA), [1992] 1 FC 25, 80 DLR (4th) 321, 5 FTR 325, [1991] FCJ No 456 (QL)  
625 Brewer Bros. v. Canada, ibid at para. 56  
626 Submissions of the Plaintiff at para. 338  
Page: 188  
This differs from the case at bar. Parliament has expressly provided for the  
protection of interests of members of a defined group the holders of documents  
and in a particular manner, viz., by requiring the posting of security to the  
satisfaction of the Commission and by ensuring the availability of a remedy to the  
holders of documents either indirectly or by direct action pursuant to s. 38(2) of  
the Act.627  
[556] In the absence of an analogous case, the Court of Appeal turned its inquiry to the  
question of whether, in the circumstances of this case, the proximity necessary to establish a new  
demonstration of a duty of care was present:  
If the claim does not fall within an established or an analogous category, but the  
harm alleged was reasonably [page182] foreseeable, proximity becomes the focus  
of the first stage of the two-stage duty of care inquiry. Where the claim is  
advanced against a regulator, the proximity inquiry will focus initially on the  
applicable legislative scheme and, secondly, on the interactions, if any, between  
the regulator or governmental authority and the putative plaintiff.628  
[557] The Court of Appeal confirmed what had been found in both Attis v. Canada and Drady  
v. Canada, that the legislative scheme did not impose a private duty of care:  
I begin with the statutory regime. As outlined above, Attis and Drady dealt with  
the same legislative scheme that is before the court in this proceeding. Both cases  
held that the scheme did not expressly or by implication create a private law duty  
of care. Nor did the scheme foreclose the existence of that duty in a particular  
situation.629  
[558] The Court acknowledged there was no reason to re-examine the question of whether the  
terms of the legislation demonstrated the presence of a duty of care:  
Neither party in this proceeding suggests that the court should reconsider the  
analysis of the legislative scheme conducted in Attis and Drady. I see no reason to  
rework that ground.  
[559] And went on to find that the fulcrum on which the issue turned was the interaction  
between the class and the defendant:  
627 Brewer Bros. v. Canada, supra (fn. 624) at para. 60  
628 Taylor v. Canada (Attorney General), supra (fn. 35) at para. 75 citing R. v. Imperial Tobacco 2011 SCC 42,  
[2011] 2 SCR 45 at paras. 43-45  
629 Taylor v. Canada (Attorney General), supra (fn. 35) at para. 101  
Page: 189  
The fate of these pleadings turns on whether they allege a sufficient interaction  
between Health Canada and the plaintiff to warrant a finding of proximity and the  
imposition of a prima facie duty of care.630  
[560] It is at this point that the Court of Appeal rejected the finding in Sauer and concluded that  
a public acknowledgment by a regulator of its public duties was insufficient demonstration of the  
interaction necessary to be the foundation for a finding that there was a duty of care owed by that  
regulator (see para. [28] above).  
[561] I turn to the telephone calls made by Trudy Tallon, her husband, Katherine Madden with  
her mother, and Judy Munro to Health and Welfare Canada. Are these telephone calls  
demonstrative of the direct contact the Court of Appeal said was not alleged in respect of the  
representative plaintiff, Kathryn Anne Taylor? (see para. [34] above). They are not. Do they  
demonstrate interaction sufficient to indicate the presence of a of duty care? They do not.  
[562] At some point in the early 1990’s, after her implant had been removed and after the  
recall, Trudy Tallon and her husband, David Bullough, who also gave evidence in this trial,  
contacted the United States Food and Drug Administration. They were referred to Health and  
Welfare Canada. They were looking for information. Generally, over the course of 1994-2001,  
each year, they telephoned Health and Welfare Canada in order to obtain information on Vitek  
Proplast implants.631 These telephone calls represent direct contact between Trudy Tallon and  
Health and Welfare Canada. The issue raised is whether such calls, made when they were,  
demonstrate the proximity necessary as the basis for a duty of care owed by Health and Welfare  
Canada to the class. These telephone calls began four years after the recall.  
[563] The telephone calls raise the prospect of the second of the two mentioned options:  
proximity supporting a private duty of care raised as a result of specific interaction between the  
parties involved.  
[564] The telephone calls made by Trudy Tallon and her husband do not represent broad public  
statements on which she relied. They are direct interactions specific to her. It is difficult to see  
how such communications could be dealt with as a common question applicable to the class as a  
whole. Surely, each case would depend on its own facts: was such a call or series of calls made?  
What was said and what reliance, if any was placed on it? On its face, calls made by the  
individual claiming a duty of care, seeking information would not demonstrate action by the  
regulator taking on such a responsibility and, based on the evidence in this case, did not do so  
here.  
[565] In the case of Katherine Madden, she never received a Vitek Proplast implant. The  
purpose of her telephone calls were to provide information, not to realize on, or create a  
relationship that was the foundation for a duty of care. Like the telephone communication  
involving Trudy Tallon and her husband, these calls, the fax and letter she sent are direct  
630 Taylor v. Canada (Attorney General), supra (fn. 35) at para. 102  
631 Transcript of Trudy Tallon (April 5, 2019) pp. 21-23 and see Transcript of David Bullough (April 5, 2019) at pp.  
39-40  
Page: 190  
communication between representatives of Health and Welfare Canada and a patient. They are  
not the sort of community or public notifications that could reasonably be taken as demonstrating  
the proximity necessary to found a private duty of care owed by the regulator to the class. Insofar  
as the individual patient, in this case, Katherine Madden, is concerned, they are a further  
demonstration of the idea that each case would have to be governed by its own facts, not as part  
of a common question within a class proceeding. Katherine Madden never received a Vitek  
Proplast Implant of any kind. There can be no private duty of care owed to her in respect of the  
treatment of such implants by Health and Welfare Canada as the regulator.  
[566] The telephone calls made by Judy Munro were to the Hotline set up for the purpose of  
communication between Health and Welfare Canada and those with concerns arising from  
having received a Proplast based implant. This was an effort to help individuals and not to take  
on a duty of care in connection with the granting of any Notice of Compliance. Judy Munro had  
retained a lawyer. These calls put him in communication with Health and Welfare Canada. This  
communication does not serve as a demonstration of the proximity on which a duty of care could  
be based. It was after the fact, that is, after the implantation and after the harm and difficulties  
had became apparent.  
[567] I return to the limitations that have descended from the history of this action. The Court  
of Appeal in considering the certification of this proceeding left open the possibility that  
misrepresentations by the Crown as to its knowledge of the risk of harm to the class, seen as a  
definable and relatively small group of consumers, could be a demonstration of proximity  
between the Crown and the class. As it has transpired, the evidence does not demonstrate the  
presence of the misrepresentations referred to by the Court of Appeal as leaving open the  
possibility of a valid claim. From a broad perspective, it is clear that the understanding of the  
potential for harm was not present as suggested by Robert Pilliar and Pierre Blais. It evolved  
over time. There was no “knowledge” that could have been, or was, the source of  
misrepresentations by the Crown. No device dedicated solely for use as a temporomandibular  
joint implant was ever issued a Notice of Compliance. Only “Block and Sheeting” received this  
form of authorization. The determination of whether the product should be used in any particular  
case rests with the health professionals involved. From a more limited perspective, the only  
specific allegation of misrepresentation rests with Information Letter 765, which says there were  
four types of Vitek Proplast temporomandibular implants that were issued Notices of  
Compliance when they had not been. As has already been said, this letter was sent to  
manufacturers and distributors. There is no evidence that any surgeon or other professional ever  
saw or read this letter and no evidence that it was relied on in furtherance of deciding to use one  
of the devices improperly referred to as having received a Notice of Compliance.  
[568] Insofar as proximity is concerned only a narrow option remains available. The  
Submissions of the Plaintiff rely on the presence of a small, definable group which stood in  
proximity to the Crown and to which, it is said, a duty of care is owed. What is a definable  
group? Identifying the group only by the alleged wrong is not enough. If the group is understood  
to be anybody who received a Vitek Proplast temporomandibular joint implant, absent some  
other defining characteristic, it could be anybody. In this case, at the time the acts of the Crown  
alleged to have been negligent took place, no one could know who, if anyone, would  
subsequently receive one of the offending implants. The names of Canadian citizens and  
Page: 191  
residents who were in pain and candidates to receive a temporomandibular joint implant would  
have been unknown and impossible to identify.  
[569] In Hill v. Hamilton-Wentworth Police Services632, the plaintiff was investigated by the  
police, arrested, tried, wrongfully convicted and ultimately acquitted but only after spending 20  
months in jail. He commenced an action against the police including a claim for negligence. At  
trial the action was dismissed. The Court of Appeal recognized the tort of negligent investigation  
but the majority found that the police were not negligent in the way the investigation had been  
carried out. The plaintiff appealed the finding that the police had not been negligent and the  
police cross-appealed from the determination that there is a tort of negligent investigation. In the  
Supreme Court of Canada, the majority held that the police are not immune from liability under  
the law of negligence and that the tort of negligent investigation exists in Canada. Police officers  
owe a duty of care to suspects. However, this was not a circumstance where the identity of the  
plaintiff was unknown and discovered only after, or as part of, the impugned investigation. To  
the contrary, he was the subject of the investigation. Because he had been identified as the  
subject of the investigation it was foreseeable that he, specifically, could suffer at the hands of an  
improper and negligent investigation. He was, in the words of the case “targeted”:633  
The analysis in Hill, in relation to whether there was sufficient proximity between  
the police investigators and a particularized suspect, is instructive. The most basic  
factor relevant to proximity is whether there is a relationship between the alleged  
wrongdoer and the victim, usually described as “close and direct” (para. 29). The  
focus is on whether the actions of the alleged wrongdoer have a close and direct  
effect on the victim.634  
[570] There is no suggestion that, from 1975 to 1988, anyone or any group known to Health  
and Welfare Canada were identified as candidates for receipt of a temporomandibular joint  
implant. There cannot be a relationship, much less a close one, where one side is not known and  
cannot be identified  
[571] In Doe v. Metropolitan Toronto (Municipality) Commissioners of Police it was alleged  
that the police were aware of the existence of a serial rapist. It was “eminently foreseeable” that  
he would strike again.635 The plaintiff alleged that by the time she was raped, the police knew or  
ought to have known that she had become part of a narrow and distinct group of potential  
victims, sufficient to support a special relationship of proximity. According to the allegations the  
police knew:  
(1) that the rapist confined his attacks to a particular and limited area of Toronto;  
(2) that the victims all resided in second or third floor apartments;  
632 2007 SCC 41 (CanLII), [2007] 3 SCR 129, 87 OR (3d) 397, 368 NR 1, [2007] CarswellOnt 6265, [2007] SCJ No  
41 (QL), 285 DLR (4th) 620, 230 OAC 253  
633 Hill v. Hamilton - Wentworth Police Services, ibid at paras. 34, 118, 132, 139, 140, 146 and 154  
634 Fullowka v. Pinkerton's of Canada Ltd., supra (fn. 620) at para. 40  
635 Doe v. Metropolitan Toronto (Municipality) Commissioners of Police, supra (fn. 622) at p. 230  
Page: 192  
(3) that entry in each case was gained through a balcony door; and  
(4) that the victims were all white, single and female.  
[572] This was sufficient to support a finding that a private law duty of care could be  
established. The harm was foreseeable and a special relationship of proximity existed.636  
Accordingly, as with Hill and unlike the case before this Court, more was known as the allegedly  
negligent actions were taking place that allowed the police to identify a relatively small group, a  
group removed from the general public, that made the risk to that group foreseeable and  
demonstrated a relationship of proximity.  
[573] There is more that serves to distinguish that case from this one. In that case, quite apart  
from the identified group, there was the allegations of an immediate relationship between the  
plaintiff and the police akin to that which existed in Hill v. Hamilton-Wentworth Police Services.  
The plaintiff alleged that the police made a conscious decision to sacrifice her in order to  
apprehend the suspect. They decided to use her as “bait”. They chose not to warn her due to a  
stereotypical belief that because she was a woman, she and others like her would become  
hysterical. This would have “scared off” the attacker, making his capture more difficult. 637  
[574] The Plaintiff referred to Fullowka v. Pinkerton’s of Canada Ltd. There was a strike in a  
mine. It became particularly contentious and violent. There was a riot which damaged property  
and injured security guards and replacement workers. Over the next weeks the situation grew  
somewhat calmer but problems did persist. There were two explosions, one which damaged a  
satellite dish and another the mine’s ventilation system. Thereafter, a miner went underground  
and planted an explosive device. Nine miners were killed in the explosion. The miners’ survivors  
sued, among others, the mine owner, the security company and the territorial government for  
negligently failing to prevent the murders. The Supreme Court of Canada upheld the decision of  
the Court of Appeal finding a duty of care owed by the government and the security company to  
the miners. There were factors which showed that the relationship between the plaintiff and both  
the security company and the territorial government were sufficiently close and direct to give rise  
to a duty of care. In the case of the government, the relationship was between the inspectors and  
the miners. The mine inspectors had a statutory duty to inspect the mine and to order the  
cessation of work if they considered it unsafe. In exercising this statutory power, the inspectors  
had been physically present in the mine on many occasions, had identified specific and serious  
risks to an identified group of workers, and knew that the steps being taken by management and  
the security company to maintain safe working conditions were wholly ineffectual.  
[575] The difference between Fullowka and this case is the same as with Hill and Doe. In the  
time before the explosion if the government inspectors had considered the problem, they would  
have been able to identify those people at risk: the miners. Here in the period leading up to the  
issuance and refusal of Notices of Compliance, if those acting in the name of the Health  
Protection Branch had considered the issue, they would not have been able to identify the group  
636 Ibid at p. 231  
637 Ibid at p. 231  
Page: 193  
at risk. No one could have known who would be likely to receive any one of the implants at  
issue.  
[576] Put differently, this is not a case like Fullowka where the group of persons to whom a  
duty of care was found to be owed was small and clearly defined. As acknowledged by the  
Plaintiff, when enforcing the Medical Devices Regulations or in evaluating submissions for a  
Notice of Compliance, Health Canada was exercising “responsibilities to the public at large” not  
to a small, discrete and identifiable group. From the regulator’s perspective, anyone in Canada  
had the potential to become a recipient of a Vitek Proplast-Teflon IPI.  
[577] This difficulty is a manifestation of the limitation that arose through the long history of  
this litigation associated with the failure to provide any definition to the size and membership of  
the class. As early as the first certification decision in 2007 the Court indicated concern for the  
suggested size of the class at 2,600. That number was offered because it was 10% of the number  
of these devices distributed in the United States. The population of Canada is 10% of that of the  
United States. The Court of Appeal anticipated that the group would be small. The number  
produced through the inspection undertaken as part of the recall was 162. Even at the first  
inspection all Proplast devices were held at Instrumentarium Inc. There is no substantive  
evidence that any of these devices were “privately imported” and, if there were some, nothing to  
suggest the numbers would run anywhere nearly as high as 2,600. And yet, in the Submissions of  
the Plaintiff there is a continued reliance on a prospective class of “approximately 2,500 – 2,600  
Canadians”.638 No one has any substantive idea of who they were, how many there are, if there  
are any at all. How can there be a small group of identified consumers? There cannot. The  
necessary “close and direct relationship” cannot be present.  
[578] Not only was there no misrepresentation as alleged before, and as relied on by the Court  
of Appeal, there was no identified group that could be foreseen as at risk. Thus, there can be no  
proximity and no duty of care.  
[579] The Plaintiff sees this differently. On her behalf it is asserted that:  
…all members of the class were known or capable of being known by Health  
Canada at the time a duty of care arose.  
[580] No statement was made as to when that was. Rather the paragraph goes on:  
Ms. Jacques testified as to the existence of Vitek customer records at  
Instrumentarium that enabled her and her colleagues to identify the number and  
location of 162 Vitek Proplast TMJ interpositional implant recipients.  
[581] Francine Jacques (Gaudette) did not testify that Health and Welfare Canada could  
identify the number and location of the recipients of the Vitek Proplast-Teflon IPI’s that had  
been sold by Instrumentarium Inc. As part of her role in monitoring Instrumentarium Inc.’s recall  
of the Proplast devices, Francine Jacques (Gaudette) was provided with a letter sent to sales  
638 Submissions of the Plaintiff at para. 3  
Page: 194  
representatives that set out information regarding its sales to hospitals and surgeons but not to  
individual patients. Neither Instrumentarium Inc. nor Health and Welfare Canada ever had that  
information. The identification of the 162 units was part of the investigation taken as part of the  
recall. This was well after any time proximity and a duty of care might have arisen. The origin of  
the alleged breach of the duty of care is said to be the negligent issuance of Notices of  
Compliance, most of which, in fact, were not granted. There were four said to have been granted  
as attested to in Information Letter 765. Whereas the Plaintiff’s position had been that these  
devices, in fact, were not granted Notices of Compliance and that the negligence was in  
misleading people as to that fact, in the Submissions of the Plaintiff it is said the Notices of  
Compliance were granted but negligently. The Notices of Compliance granted were for Block  
and Sheeting” and these devices were for a broader set of purposes and not for use as  
temporomandibular implants. There is no substantive evidence that anyone did use these devices  
for that purpose.  
[582] The paragraph in the Submissions of the Plaintiff goes on:  
Instrumentarium’s files would have reasonably disclosed all other Vitek implant  
customers and their locations across Canada.  
[583] It is not clear there were any other Vitek Proplast customers. Francine Jacques (Gaudette)  
did instruct Instrumentarium Inc. to hold back all Proplast products, not just the interpositional  
implants.  
[584] The paragraph in the Submissions of the Plaintiff concludes:  
Health Canada was also in possession of a defined Vitek consignee list  
comprising [200]639 surgeons at least one of whom had engaged in the private  
importation of Vitek Proplast TMJ implants.640  
[585] The list of Canadian surgeons was identified, not as a list of consignees, but as a list of  
doctors who had expressed an interest in the product. In any case, the tripartite meeting which  
involved Canadian, American and British regulators and which introduced the fact that a list of  
Canadian surgeons existed took place on May 28, 1991. It was not made available to Health and  
Welfare Canada until June 18, 1991. This was after the recall. The one surgeon being referred to  
is the Manitoba oral surgeon the Submissions of the Plaintiff say secured implants “through  
private importation”.641 I repeat what has already been said, the memorandum of Robert Scales  
reports that the surgeon purchased implants from Instrumentarium Inc. (see para. [438] above).  
[586] The Submissions of the Plaintiff also suggest that proximity is established through  
contact between the Instrumentarium Inc. and the inspectors:  
639 The number that appears in the Submissions of the Plaintiff is 207. I believe this to be a typographical error. The  
consignee list was said, in evidence, to be of 200 surgeons. 207 is the total number of Vitek Proplast IPI TMJ  
implants accounted for by Francine Jacques (Gaudette) when she visited Instrumentarium Inc. as part of the recall.  
640 Submissions of the Plaintiff at para. 281  
641 Ibid at para. 440  
Page: 195  
…In this case Ms. Jacques testified, Health Canada had prior contact with  
Instrumentarium going back seven years prior to the inspection to 1979 and as  
recently as December 1985 when Instrumentarium sought information on the  
importation of a Part V device under the same regulatory controls as Vitek  
Proplast TMJ implants. Furthermore, both Ms. Jacques and Mr. Scales testified to  
the regular review of customs manifests related to the importation of medical  
devices. The customs surveillance program, formally instituted in 1983, would  
have resulted in multiple points of contact between Instrumentarium and Health  
Canada  
[587] The first sentence of this paragraph states:  
With regards to direct and personal dealings, the Supreme Court looked at the  
extent of prior inspections and contact between the inspectors…642  
[588] This is a reference to Fullowka. The circumstances there were substantially different than  
they are here. In that case, the Supreme Court of Canada observed:  
In exercising this statutory power, the inspectors had been physically present in  
the mine on many occasions, had identified specific and serious risks to an  
identified group of workers and knew that the steps being taken by management  
and Pinkerton’s to maintain safe working conditions were wholly ineffectual.  
[589] In the case before the Court there were not “frequent visits” to Instrumentarium Inc.  
There had been two inspections. The purpose was not to identify specific or serious risks. To the  
contrary, these visits were part of a program directed to working in a cooperative manner to  
instruct and advise, in this case Instrumentarium Inc., as to the requirements necessary to bring  
product to market and to attempt to bring about voluntary compliance with the amended  
regulations. No serious risks had been identified or were apparent. This only came later.  
Moreover, this does not deal with a relationship between the inspector (the Crown) and the  
victim with whom proximity is required to found the presence of a duty of care:  
The focus is on whether the actions of the alleged wrongdoer have a close and  
direct effect on the victim. In Hill, the Chief Justice emphasized that the  
relationship between the police and a particularized suspect was closer than that  
between the regulator and the public which had been in  
issue in Edwards and Cooper. In those cases, the public officials were acting in  
relation to a third party, that is, the person being regulated who, in turn, interacted  
with the claimant (para. 33). In contrast, in Hill the police interacted directly with  
the suspect who was the claimant.643  
[590] As noted in the Submissions of the Defendant, the issuance of Notices of Compliance  
does not have a direct effect on members of the purported class because whether, what, when and  
642 Ibid at para. 282  
643 Fullowka v. Pinkerton's of Canada Ltd., supra (fn. 620) at para. 40  
Page: 196  
how to implant is always the decision of an intermediary, a doctor, in consultation with a patient.  
There is nothing in the issuance of a Notice of Compliance that creates a distinct of more direct  
connection to the plaintiff than to the public at large.  
[591] For the most part, the submissions made as demonstrating proximity are not that. They  
reflect on actions and relationships that took place after the concerns, problems and difficulties  
with Vitek Proplast temporomandibular implants were established and accepted. These events do  
not found proximity and a duty of care. They are allegations that a supposed duty of care, already  
established, was breached. As in the Submissions of the Defendant:  
At its highest, the plaintiff’s claim amounts to a series of allegations that Health  
Canada breached the [Food and Drugs Act] by not taking the enforcement actions  
to prevent Vitek’s TMJ devices from being sold in Canada before 1988, and  
breached the [Medical Devices Regulations] by issuing [Notices of Compliance]  
for Proplast facial block and sheeting (and apparently also for TMJ devices) in  
1988. …644  
[592] It is possible that a duty of care could arise later, say at the time of the recall. This would  
require the taking on of a legal responsibility, through a proximity established at that later time,  
in this case once the problems had been identified. Presumably, an assumption of such a  
responsibility taken at that time would suggest, when things go wrong, the possibility of liability  
for actions and activities that occurred thereafter. To put it more clearly, any responsibility for  
negligence would not be in respect of any harm associated with the implanting of these devices  
but only for whatever extension to the harm took place after the duty of care was assumed and as  
a result of actions taken at that later time. I expect, it would apply to any delay in treatment  
caused as a result of demonstrated negligence that occurred after taking on of a duty of care. As  
it is, no submissions were made on behalf of the Plaintiff that establish the existence of a duty of  
care with respect to the activities surrounding the recall as opposed to the breach of a supposed  
duty of care associated with the granting and refusal to grant Notices of Compliance.  
[593] This takes these reasons back to the distinction between this case and Hill, Doe and  
Fullowka. Proximity, and therefore a duty of care, cannot arise from the activities that are the  
foundation of the claim (the investigation, the rape, the explosion and in this situation the recall  
and associated activities). It arises from a relationship already in place.645 In this case, the  
plaintiff has failed to establish proximity between Health and Welfare Canada and members of  
the supposed class. Without proximity, there is no duty of care. Without a duty of care there can  
be no liability for negligence.  
[594] This being so there is no need for me to proceed further. Nonetheless recognizing the  
time this has taken, the need for these issues to be resolved and recognizing the prospect that,  
regardless of the outcome, this matter may be the subject of an appeal, I go further.  
Foreseeability not being questioned, if there was proximity, a prima facie duty of care would be  
644 Submission of the Defendant at para. 297  
645 In Hill the plaintiff was targeted. In Doe the plaintiff lived in a targeted part of the city in an apartment with an  
accessible balcony and in Fullowka the miners had interaction with the mine inspectors.  
Page: 197  
established. This would take these reasons to the second stage of the test from Anns v. Merton  
London Borough Council. It is for the Defendant, the Crown, to establish the presence of  
ancillary policy reasons that dictate that the duty should be limited or set aside. This inquiry  
reflects “on the broad societal and legal implications of imposing a duty of care”.646 As such it  
extends beyond considerations bound up in the particular relationship:  
government immunity for policy decisions is not based on the parties'  
relationship, but "is better viewed as an immunity imposed because of  
considerations outside the relationship for policy reasons -- more precisely,  
because it is inappropriate for courts to second-guess elected legislators on policy  
matters"647  
[595] Given the history of this proceeding, I take the time to point out that the decision of the  
Court of Appeal in 2012 never got to this issue:  
The questions posed in this special case focus exclusively on the first stage of the  
duty of care inquiry...648  
[596] An examination of the question should begin with a consideration of the sources  
available to establish the policy which informs the actions being scrutinized. In our lexicon  
“policy” is an amorphous word. It lacks focus. It is not uncommon for Ministers of the Crown to  
make announcements as to the “policy” of the government. Rarely, is it known what  
consideration has gone into or who has been involved in developing the expressed ideas. A  
speech from the throne, which opens a new parliamentary or legislative session is a more formal  
recitation of the policy of the government of the day. The Planning Act649 contains a provision  
allowing for the publication of “policy statements”.650 The Planning Act requires that decisions  
made or advice given by the responsible agencies and government actors be consistent with those  
policy statements.651 The principal source to understand the applicable policy for consideration  
646 Attis v. Canada (Health),supra (fn. 22) at para. 73 referring to Cooper v. Hobart, supra (fn. 599) at para. 37 and  
Holland v. Saskatchewan, [2008] S.C.J. No. 43, 2008 SCC 42 (CanLII), EYB 2008-136658, J.E. 2008-1434, 167  
A.C.W.S. (3d) 427 at para. 10 and see Drady v. Canada (Health), supra (fn. 3) at para. 24, Hill v. Hamilton -  
Wentworth Police Services supra (fn. 632) at para. 46  
647 Attis v. Canada (Health), supra (fn. 22) at para. 32 quoting Cooper v. Hobart, [2001] 3 S.C.R. 537, [2001] S.C.J.  
No. 76, 2001 SCC 79 (CanLII), 206 D.L.R. (4th) 193 at para. 38  
648 Taylor v. Canada (Attorney General), supra (fn. 35) at para. 73  
649 R.S.O. 1990, c P. 13  
650 Planning Act s. 3 (1) states:  
The Minister, or the Minister together with any other minister of the Crown, may from time to  
time issue policy statements that have been approved by the Lieutenant Governor in Council on  
matters relating to municipal planning that in the opinion of the Minister are of provincial  
interest.  
[Emphasis added]  
651 Planning s. 3(5) and (6) say, in part:  
Page: 198  
of stage two of the test in Anns v. Merton London Borough Council is the statutes and regulations  
that inform the issues at hand. In this case that would be the Food and Drugs Act and the  
Medical Devices Regulations. These are legislative emanations of the governments and stand as  
substantive demonstrations of its intention in respect of medical devices. I begin with this. The  
mandate of the Minister and therefore the Ministry is not, and was not, to a particular group or  
segment of our society but to all of us.  
[597] The responsibility of the Minister of Health is to the people of Canada:  
The powers, duties and functions of the Minister extend to and include all matters  
over which Parliament has jurisdiction relating to the promotion and preservation  
of the health of the people of Canada not by law assigned to any other department,  
board or agency of the Government of Canada. 652  
[598] The intended direction of this responsibility was explained in Attis v. Canada:  
… the umbrella statute of the Department of Health Act, at s. 4, provides that the  
Minister’s obligations are to the people of Canada for the promotion of their  
health and the prevention of risk generally. Thus, under this statute, the Minister’s  
duty is to the people of Canada as a whole, not to individual residents.653  
[599] Even at this overarching phase, the policy directive in the legislation is contrary to any  
understanding that a duty of care is to be owed by the Crown to any individual or presumably  
any group of individuals. The responsibility is an umbrella covering us all through responsible  
regulation as opposed to an assumption of direct or immediate liability.  
[600] The regulation of food, drugs, cosmetics and medical devices in Canada is carried out  
under the legislative authority of the Food and Drugs Act. It was first enacted in 1920. In 1953  
Parliament added a provision dealing with medical devices.654 At that time, the Minister of  
(5) A decision of the council of a municipality, a local board, a planning board, a minister of the  
Crown and a ministry, board, commission or agency of the government, including the Tribunal,  
in respect of the exercise of any authority that affects a planning matter,  
(a) shall be consistent with the policy statements issued under subsection (1) that are in  
effect on the date of the decision;….  
(6) Comments, submissions or advice affecting a planning matter that are provided by the  
council of a municipality, a local board, a planning board, a minister or ministry, board,  
commission or agency of the government,  
(a) shall be consistent with the policy statements issued under subsection (1) that are in  
effect on the date the comments, submissions or advice are provided;…  
652 Department of Health Act S.C 1996, c. 8 at s. 4(1)  
653 Attis v. Canada (Health), supra (fn. 22) at para. 54  
654 SC 1953, c. 38  
Page: 199  
National Health and Welfare emphasized that the Food and Drugs Act created duties to the  
public, as a whole, and that the legislation depended heavily on the co-operation of industry:  
The purpose of the bill of course is to protect the Canadian people in matters of  
health as well as fraud in the manufacturing and sale of food and drugs. The  
administration of the measure depends upon the co-operation that the officials of  
the department are able to enjoy with industry… The bill is concerned with the  
prohibition of things that are injurious to health and that are unfit for use, and with  
the prevention of deception in the manufacture and sale of goods consumed by the  
public.655  
[Emphasis added]  
[601] Prior to the promulgation of the first Medical Devices Regulations, in 1975, medical  
devices were regulated solely by the provisions of the Food and Drugs Act. Through a series of  
prohibitions, the legislation placed the obligation for the safety of medical devices on the  
manufacturers and distributors, not on the Crown:  
No person shall sell any device that, when used according to directions or under  
such conditions as are customary or usual, may cause injury to the health of the  
purchaser or user thereof.656  
[602] It is the person “selling” on whom the obligation is placed:  
Importantly, s. 19 of the FDA, deals directly with the safety of medical devices,  
explicitly places the obligation for the safety of the devices on the manufacturer  
and distributor when it says “no person shall sell” any unsafe device. As the  
motion judge concluded, no obligations are placed on the government.657  
[603] The same can be said for s. 20 of the Food and Drugs Act. It imposes a further  
prohibition. This one on packaging:  
No person shall label, package, treat, process, sell or advertise any device in a  
manner that is false, misleading or deceptive or is likely to create an erroneous  
impression regarding its design, construction, performance, intended use,  
quantity, character, value, composition, merit or safety.658  
[604] Part II of the Food and Drugs Act, as it was, and as it is, sets out the Crown’s powers of  
administration and enforcement. Under this part, any person designated as a Food and Drug  
Inspector had and has powers of entry and inspection for the purposes of enforcing compliance  
655 House of Commons Debates, April 21, 1953 at p. 4141  
656 1952-53, c. 38, at s. 19.  
657 Attis v. Canada (Health), supra (fn. 22) at para. 56  
658 Food and Drugs Act 1970 c. F. 27 and 1985 F. 27 both at s. 20  
Page: 200  
with the Food and Drugs Act and the accompanying regulations.659 As the Court of Appeal has  
held, these powers of enforcement are entirely discretionary. They are not mandatory:  
While the FDA and its regulations provided mechanisms for Health Canada to  
enforce compliance, enforcement was entirely discretionary. It was not  
mandatory. Moreover, the legislative scheme envisaged no relationship between  
Health Canada and the consumer of the medical devices. 660  
[605] This demonstrates that the role of the Crown is within the legislative scheme and the  
policy that informs it. It is not one of legal responsibility, that is the role of those who bring the  
product to the market. The role of the Crown is to see that bringing these products to market is  
done in a fashion that meets the policy directive of the legislative scheme.  
[606] The Medical Devices Regulations were introduced on September 2, 1975.661 At the outset  
the Crown was not required to play an active role in the entry of new devices into the market in  
Canada. At that time, the regulations prohibited the sale of a medical device in Canada unless  
tests had been conducted indicating that the benefits claimed to be obtainable through the use of  
the device were justified and that such evidence was available in Canada. Manufacturers were  
only required to provide Health and Welfare Canada with evidence establishing the safety of a  
device when requested to do so by Health and Welfare Canada.662  
[607] Part II of the 1975 Medical Devices Regulations (Device Notification and Material)  
established new requirements for notifying Health and Welfare Canada of medical device sales.  
Under this part, a manufacturer of a device (or a person authorized to act on its behalf) was  
required to provide Health and Welfare Canada with a notification of sale before April 1, 1976,  
or within ten days of the date of first sale in Canada, whichever was later.663 The 1975 Medical  
Devices Regulations did not require Health and Welfare Canada to conduct any review of the  
safety or efficacy of a device prior to its entry into the Canadian market. The general  
understanding was that the work in respect of bringing medical devices to market was to be  
undertaken by the industry (the manufacturer and the distributor).  
[608] Pre-market review for “new devices” was added to the Medical Devices Regulations on  
March 25, 1977.664 Under the 1977 Medical Devices Regulations, a manufacturer of a “new  
device” was prohibited from selling the device or advertising it for sale in Canada unless the  
manufacturer first received a Notice of Compliance from Health and Welfare Canada.665 To  
obtain a Notice of Compliance, the Medical Devices Regulations required the manufacturer to  
submit to Health and Welfare Canada evidence of the safety and efficacy of the device.666 Where  
659 Ibid at ss. 22-32 and 1985 F. 27 at ss. 22-37  
660 Drady v. Canada, supra (fn. 3) at para. 38  
661 Medical Devices Regulations SOR/75-526  
662 Ibid at ss. 13 and 27 as well as Agreed Statement of Facts at para. 16  
663 Ibid at s. 23  
664 Medical Devices Regulations SOR/77-258 Sch. II, s. 28  
665 Ibid at ss. 29 and 30  
666 Ibid at Sch. II, s. 31  
Page: 201  
Health and Welfare Canada was not satisfied that the manufacturer had provided substantial  
evidence of the required criteria, it was to refuse to issue a Notice of Compliance and to inform  
the manufacturer of the reasons for the refusal.667  
[609] The responsibility to provide the information that informed pre-market review was the  
manufacturers.  
[610] In deciding that a Notice of Compliance was to be issued, the Director, who made that  
determination, was not making a decision by which the Crown took on any of the legal  
responsibility associated with the eventual safety or efficacy of the device:  
The Regulations were clear that the Director "shall" issue the notice of  
compliance if he or she is satisfied that the manufacturer has provided "substantial  
evidence" to support the criteria set out in s. 36(a). The Director did not make a  
determination as to the ultimate efficacy of the device, the risks associated with  
the use of the device, or the adequacy of any warnings or instructions provided  
with the device.668  
[611] Health and Welfare Canada did not conduct its review for substantial evidence of safety  
to humans in a vacuum. Under section 36(a)(ii) of the Medical Devices Regulations, Health and  
Welfare Canada’s review for substantial evidence of safety and efficacy was guided by the  
intended purpose and use of the device specified by the manufacturer under section 35(1)(a)(ii).  
(see para [77] above). All of the materials and information were to be submitted by the  
manufacturer.669 The issue for Health and Welfare Canada’s consideration was whether the  
manufacturer had submitted substantial evidence that the new device could be used “for the  
purpose and under the conditions of use recommended by the manufacturer without undue risk to  
humans”670 [Emphasis added]. The Medical Devices Regulations did not require, and Health and  
Welfare Canada did not conduct, independent safety and efficacy testing as part of the process of  
reviewing submissions for a Notice of Compliance:  
The regulations in force during the time frame defined by the appellants simply  
particularized and provided mechanisms to enforce compliance with the  
legislation's objective. A reading of the legislative history of the regulations  
discloses that there was no obligation on Health Canada to undertake safety and  
efficacy testing, or to engage any other compliance or enforcement mechanism.671  
667 Medical Devices Regulations 1978 c. 871, s. 36(b)  
668 Taylor v. Canada (Attorney General), supra (fn. 35) at para. 59  
669 The Medical Devices Regulations s. 35(1) begins:  
For the purposes of obtaining a notice of compliance the manufacturer of a new device shall  
submit to the Director… (quoted at para. [77] above)  
670 Medical Devices Regulations s. 36(a)(ii) (quoted at para. [78] above)  
671 Attis v. Canada (Health), supra (fn. 22) at para. 57  
Page: 202  
[612] In February 1981, Health and Welfare Canada made a submission to the Cabinet  
Committee on Social Development for additional funding for the medical devices program.672  
The need for additional funding was due, in part, to the proliferation of medical devices coming  
into the Canadian market.673 With the request for additional resources, Health and Welfare  
Canada also asked Cabinet to define Canada’s policy with respect to the regulation of medical  
devices.674 There were three different regulatory approaches that ministers were asked to  
consider: the conventional approach; self-regulation; and the collaborative approach.675 The  
choice provided was reviewed in the evidence provided by Janice Hopkins. The collaborative  
approach was selected. Under this approach Health and Welfare Canada would depend primarily  
on collaboration with industry and professional users (i.e. doctors, dentists, surgeons, hospitals,  
etc.). The goal was to ensure the safety and efficacy of medical devices, while prioritizing  
governmental regulation for devices that presented the highest degree of risk to individual  
users.676 In practical terms, a collaborative regulatory approach would permit the Department to  
ensure “reasonable probability of safety and effectiveness of the highest priority inventions for  
open marketing” and the ability to take corrective and preventative actions in response to reports  
of the most severe device failures:677  
The regulations simply authorized Health Canada to enforce the various aspects  
of the compliance requirements if it chose to do so. Thus, Health Canada was akin  
to an overseer or watchdog, able to employ discretionary, but not mandatory,  
enforcement of the legislative scheme.678  
[613] Emblematic of this co-operative, collaborative approach, in which the Crown is more  
watchdog than police officer, is the understanding that the issuance of a Notice of Compliance  
did not signify Health and Welfare Canada’s approval of the device:  
A Notice of Compliance issued by the [Health Protection] Branch after evaluation  
of the submission does not signify approval. It does, however, provide users with  
assurance that the Branch is satisfied that the manufacturer has carried out tests  
and has submitted appropriate results to demonstrate a reasonable probability of  
safety and effectiveness in humans. The onus of ensuring safety and effectiveness  
of the device remains with the manufacturer.679  
[614] In 1984, Health and Welfare Canada published a Guide to the Preparation of a  
Submission Pursuant to Part V of the Medical Devices Regulations. It was provided to  
672 Exhibit 55, T.1 and T. 2 (The Cabinet Committee on Social Development was comprised of a selection of 10  
ministers, including the Minister of National Health and Welfare (Transcript of Janice Hopkins (June 10, 2019) at p.  
21; Exhibit 55, T. 3)  
673 Transcript of Janice Hopkins (June 10, 2019) at p. 45  
674 Ibid at p. 46-47  
675 Exhibit 55, T. 2 pp. 9-11  
676 Transcript of Janice Hopkins (June 10, 2019) at pp. 49-50  
677 Exhibit 55, T. 2 p. 23  
678 Attis v. Canada (Health), supra (fn. 22) at para. 57  
679 Exhibit 19 (Information Letter No. 638 January 12, 1983) at p. 2  
Page: 203  
manufacturers and distributors. It made clear their responsibility and the limits on the role of the  
Crown:  
It must be noted that there is no authority or mechanism under the Food and  
Drugs Act to approve a medical device prior to its sale in Canada. It is the  
responsibility of the manufacturer to ensure that the regulatory requirements are  
met.680  
[615] The limits of what could be taken from the issuance of a Notice of Compliance was  
explained by Pierre Blais:  
With respect to medical devices such as dental implants, Canada’s Health  
Protection Branch does not “approve the use of these products. It issues a  
document called a Notice of Compliance”; this confirms that the manufacturer has  
complied with basic and usually very modest disclosure requirements for the  
manufacturing technology in the clinical history of the product.  
It does not mean that the clinical safety is assured, that the manufacturing process  
is scientifically valid, that the embodied technology is the best available or that  
the quality assurance protocol is most appropriate. Furthermore, there is no  
mandate to verify or duplicate the scientific and clinical data submitted or  
independently test the products to confirm that they are consistently manufactured  
using the stated methods or produced to the claimed levels of quality assurance.681  
[616] This approach is the manifestation of the direction, found in the Medical Devices  
Regulation, to strive in each case to find the appropriate balance between “efficacy” on the one  
hand, and “safety” on the other.682 It was understood that, in the search for benefits, there are  
risks and that some would, in the normal course, be realized:  
It was understood that a lot of the problems started to occur with products by the  
time they reached in the fifth or the fourth year and that’s when, you know, all the  
difficulties started to come and all the failures or whatever was happening would  
start to get noted. In a lot of, in a lot of cases, you know, it was believed, you  
know, in five years, we will start knowing exactly where this stands.683  
[617] The point of this policy was not to set the Crown with a duty of care. Rather it was to  
allow for reasonable parameters within which to find the balance between benefit and risk which  
was engaged when any device was brought to market. The evidence, at trial, produced examples  
of what can be anticipated. Heather Sheardown explained that, in the United States, cornea  
implants were allowed into the market. There was a failure rate of 50%. Some recipients went  
680 Exhibit 48 (Guide to the Preparation of a Submission Pursuant to Part V of the Medical Devices Regulations) at  
p. 3  
681 Exhibit 34, T. 56; Transcript of Pierre Blais (May 8, 2019) at p. 177  
682 Medical Devices Regulations 1978 c. 871, s. 36 (quoted at para. [78] above)  
683 Transcript of Nirmala Chopra (April 23, 2019) at pp. 26-27  
Page: 204  
blind. In Canada, surgeons were eager to utilize Cotrel rods to assist their patients. They had to  
wait until the required material was provided and a Notice of Compliance issued. In the perfect  
world, the former never would have happened; the latter would have been permitted into the  
market more quickly. In the case of Cotrel rods, it can be said that the delay was made shorter, in  
part, through the collaboration between the manufacturer and those responsible for receiving and  
reviewing the submissions that led to the issuance of Notices of Compliance.  
[618] If I am wrong in what I have found; if the analysis required by the first stage in the test  
put in place by Anns v. Merton London Borough Council demonstrates there is a prima facie  
duty of care owed by the Crown to the members of the class, I would find that there are residual  
policy reasons which justify denying liability. The policy, which the legislation and regulation  
supports, is directed to all Canadians and to our collective benefit bringing to those in need  
medical devices that will bring relief. The balance between efficacy and safety which is at the  
foundation of this policy accepts that, for some, there are risks that may be realized. However, to  
fasten the Crown with a duty of care to those individuals would upset the policy. The balance  
would be skewed by the need of the Crown to minimize its liability by refusing to allow new  
devices into the market until it had assurance of the long-term benefit and absence of risk. In  
such circumstances there might well be fewer cornea implants but there would also be more, I  
suggest many more, devices like Cotrel rods where benefit would be unnecessarily delayed.  
[619] This is still not the end of what is required to bring this case to an end. The Supreme  
Court of Canada has distinguished the policy concerns of stage two of the test in Anns from what  
is referred to as “operational” concerns:  
It is at this second stage of the analysis that the distinction between government  
policy and execution of policy falls to be considered. It is established that  
government actors are not liable in negligence for policy decisions, but only  
operational decisions. The basis of this immunity is that policy is the prerogative  
of the elected Legislature. It is inappropriate for courts to impose liability for the  
consequences of a particular policy decision. On the other hand, a government  
actor may be liable in negligence for the manner in which it executes or carries  
out the policy. In our view, the exclusion of liability for policy decisions is  
properly regarded as an application of the second stage of the Anns test. The  
exclusion does not relate to the relationship between the parties. Apart from the  
legal characterization of the government duty as a matter of policy, plaintiffs can  
and do recover. The exclusion of liability is better viewed as an immunity  
imposed because of considerations outside the relationship for policy reasons –  
more precisely, because it is inappropriate for courts to second-guess elected  
legislators on policy matters. 684  
[620] Are there operational concerns with what has taken place in respect of Vitek Proplast  
temporomandibular joint implants which would suggest a breach of a duty of care if any had  
been found to exist, and to be maintained even in the face of the particular policy considerations  
684 Cooper v. Hobart, supra (fn. 599) at para. 38  
Page: 205  
to be applied? In such circumstance what would be the applicable standard of care? The standard  
of care rests on the idea of reasonableness. What would a reasonable person with the requisite  
knowledge, experience and responsibilities do in the situation being evaluated? In Hill v.  
Hamilton-Wentworth Regional Police Services Board the proposition was simply stated:  
the standard of care is based on what a reasonable police officer would do in  
similar circumstances.685  
[621] The same point is more broadly said in Ryan v. Victoria (City) as follows:  
Conduct is negligent if it creates an objectively unreasonable risk of harm. To  
avoid liability, a person must exercise the standard of care that would be expected  
of an ordinary, reasonable and prudent person in the same circumstances. The  
measure of what is reasonable depends on the facts of each case, including the  
likelihood of a known or foreseeable harm, the gravity of that harm, and the  
burden or cost which would be incurred to prevent the injury. In addition, one  
may look to external indicators of reasonable conduct, such as custom, industry  
practice, and statutory or regulatory standards.686  
[622] Generally speaking, a reasonable regulator’s job is to administer its authorizing statute.  
Those powers should be exercised in light of relevant information and for the purpose of  
advancing the statute’s objectives. Reasonable regulators evaluate relevant information and  
choose a regulatory response in good faith based on their assessment of what best promotes the  
statutory purpose in the circumstances. The mere existence of a power to control a risky situation  
does not mean that the reasonable regulator must deploy that power in all cases to eliminate risk,  
particularly when judged with the benefit of hindsight.687  
[623] The fundamental allegation of negligence is that those acting on behalf of the Crown  
knew or should have recognized the dangers of Proplast and were negligent in allowing  
temporomandibular joints that included Proplast to be used in Canada, and that the failure  
extended to the time when they did act in response to those dangers. Those actions also breached  
the standard relying on what the reasonable regulator would or should have done in that  
situation. It will be clear to anyone reviewing these reasons, particularly the section entitled:  
“What Was Known About Proplast, by Whom and When Was It Known” that I would be  
unprepared to find that the standard of care as it is applies to this situation was breached.  
[624] The actions and statements of those involved at the material time do not serve to support  
the allegation that the Crown fell short of the standard. Pierre Blais suggested in his evidence  
that he sought the prohibition on the use of Proplast as far back as 1977 when he attended the  
Gordon Conference at which, as he described it, pandemonium broke out in opposition to the  
685 Hill v. Hamilton-Wentworth Police Services, supra (fn. 632) at para. 44.  
6861999 CanLII 706 (SCC), [1999] 1 SCR 201, 168 DLR (4th) 513, [1999] 6 WWR 61, [1999] SCJ No 7 (QL), 59  
BCLR (3d) 81, 117 BCAC 103 at para. 28  
687 This paragraph is a quotation from the Submissions of the Defendant (at para. 347) which I adopt as an  
appropriate explanation of reasonableness as it should be applied in this case.  
Page: 206  
presentation made by Charles Homsy, identified during the trial as the individual who developed  
Proplast. Pierre Blais told the Court that when he returned to Canada, he proposed a prohibition  
on the use of Proplast in Canada, that this recommendation was supported by his immediate  
superiors but was rejected by more senior officials when the idea was taken to them. There is  
nothing which supports this, no document or any other evidence. Pierre Blais went on to suggest  
that his concern resulted in a continuous set of discussions which went on over the 14 years of  
his employment with the Health Protection Branch and that it involved the “mere totality of the  
early generation of evaluators” and later “other members of the department”. He said there was  
“unanimity in the belief that the product was very damaging”. When taken as a whole none of  
this is supported by the evidence.  
[625] The only document that refers to the Gordon Conference is the one from May 18, 1981  
entitled “A Need for Enhanced Regulatory Control of Invasive Medical Devices.” It does not  
recommend prohibition. It suggests that these products should be placed in a special category  
and made subject to close supervision. In the end this document and its reuse the following year  
contributed to the inclusion of implants that were to be left in the body for 30 days on the  
Schedule attached to Part V of the Medical Devices Regulation, meaning they were to be treated  
as “new devices” the use of which required recognition through the granting of a Notice of  
Compliance. This was akin to what Pierre Blais was shown to have requested in the document. It  
was accepted by Pierre Blais as appropriate given what was known at the time.  
[626] Pierre Blais took part in the preparation of a book: “Biomaterials in Reconstructive  
Surgery.” The book included a chapter about Proplast. The chapter recognizes concerns. More  
study was required. Pierre Blais was one of the editors of the book. Collectively they included  
the chapter because it recognized the possibility that Proplast might still fulfill at least some of its  
promise. Pierre Blais did not indicate that he had any objection to this inclusion; to the contrary  
he agreed with the decision. Interestingly, this decision was made in 1979, four years before  
publication and three years after the Gordon Conference.  
[627] There is nothing that confirms there was any commonly held view, within the Health  
Protection Branch, that Proplast was dangerous or that Pierre Blais had so informed his  
colleagues. Nancy Shadeed was aware of Pierre Blais but reported that he never discussed his  
research or laboratory work with her. He never reviewed any concerns he had about materials  
used in the manufacture of medical devices. She had no independent awareness of his  
research.688 Similarly Richard Lawuyi did not discuss the Vitek implants, or for that matter  
anything else of substance with Pierre Blais.689 Louis Boulay was aware of Pierre Blais but  
suggested that with the 1983 amendment to the Schedule to Part V of the Medical Devices  
Regulations Pierre Blais “was more involved on the research side than the review side.” It would  
have been unusual for Pierre Blais to have been involved in pre-market review. Pierre Blais  
never approached Louis Boulay about Proplast.690 In her evidence, Lindsay Blaney made no  
particular reference to any communication with Pierre Blais in respect of Proplast or any other  
688 Transcript of Nancy Shadeed (May 23, 2019) at p.67  
689 Transcript of Richard Lawuyi (May 28, 2019) at pp. 55, 76 (On one occasion they discussed Pierre Blais’  
research on silicone breast implants.)  
690 Transcript of Louis Boulay (June 11, 2019) at p. 20, 21 and 22  
Page: 207  
issue. Francine Jacques (Gaudette) did discuss Cotrel rods with Pierre Blais and had at least one  
other conversation with him but nothing of great consequence. 691 Janice Hopkins was aware of  
Pierre Blais but never had an occasion to discuss Proplast with him.692 One person who did speak  
with Pierre Blais was Nirmala Chopra. She testified that the evaluators consulted him often  
regarding different types of material. She said that the 1981 to 1982 period was when they began  
to hear about Proplast. They were not sure “what it was doing… we needed to study it more.”693  
It is evident that Nirmala Chopra did review Proplast and other materials with Pierre Blais. Her  
understanding was that the evaluators also spoke with him. This, it would seem, is not accurate.  
She directed Nancy Shadeed to speak to Pierre Blais 694but, from the evidence of Nancy  
Shadeed, she did not. By the time Richard Lawuyi conducted his review, Nirmala Chopra was no  
longer with the Medical Devices Bureau.  
[628] What do I take from this? It may be that the Crown believes that the evidence of Pierre  
Blais should be disregarded. I do not understand why it was thought necessary to prepare, what  
on its face seems to be, the approval of the paper: “Frangible, Degradable and Dispersible  
Implant Materials” by copying what was a proper approval of another paper. However, I am not  
prepared to allow that fact to jettison all that was offered by Pierre Blais. As I have said, he was,  
for a significant period of time, considered to be a valued employee. On the other hand, the  
Plaintiff believes that Pierre Blais is the light which guides the circumstances as she sees them.  
That is to say that the danger presented by Proplast was clear from the beginning, that the  
officials of the Crown knew this, or should have recognized it and the failure to act was  
demonstrative of their collective negligence. I do not accept this either. It is more than forty  
years since Pierre Blais went to work for the Medical Devices Bureau and that long since he  
attended the Gordon Conference, which is where the evidence as to his personal experience with  
Proplast began. Memory is uncertain. It can mislead us as to the substance and nature of our  
involvement in events long passed. In the absence of any specific confirmation I do not accept  
that Pierre Blais pushed for the prohibition of Proplast. To the contrary, he accepted the changes  
to the Medical Devices Regulations as typical of the evolution of this sort of regulatory tool and  
the outcome of the request for change, being the addition of implants that would remain in the  
body for 30 days as subject to Part V of the Medical Devices Regulations, as providing a level of  
protection for the public. It was a form of “enhanced regulatory control”: a new classification  
criterion for devices subject to Part V requirements (see para. [130] above). At the material time,  
as opposed to when he appeared at the trial, Pierre Blais agreed that the chapter of the Rubin text,  
that dealt with Proplast, should remain in that publication because it was possible that Charles  
Homsy was right, that Proplast could be useful and of assistance to patients. I find that Pierre  
Blais was not central, as he believes himself to have been, to whatever debate took place inside  
the Health Protection Branch. For the most part, those who testified, and were directly involved,  
never discussed Proplast with him. It may be that Nirmala Chopra and Pierre Blais talked about  
Proplast but there is little that suggests these conversations went further. It should not be  
forgotten that she left after Nancy Shadeed found the submissions made with respect to Propast  
691 Transcript of Francine Jacques (June 17, 2019) at p. 82-83, 95  
692 Transcript of Janice Hopkins (June 10, 2019) at p. 105  
693 Transcript of Nirmala Chopra (April 11, 2019) at p. 25-26 and (April 23, 2019) at p. 28  
694 Transcript of Nirmala Chopra (April 24, 2019) at pp.76 and 100  
Page: 208  
insufficient, but before Richard Lawuyi recommended that Proplast Block and Sheeting be  
issued Notices of Compliance.  
[629] In short I do not accept that anything that Pierre Blais said should be taken as showing  
negligence by or on behalf of the Crown. There was no consensus against the use of Proplast.  
The early signs were positive as demonstrated by the work of Wolford and Gallagher, Kiersch,  
Brown, Moriconi as well as Block, Kent and Homsy, all reported on in evidence from Doran  
Ryan. This was joined by the retrieval analysis conduced by the University of Minnesota School  
of dentistry in the early 2000’s and presented at the 68th Annual Meeting and Scientific Sessions  
of the American Association of Oral and Maxillofacial Surgeons. It was confirmed by the  
literature review undertaken by Christopher Ober. Heather Sheardown reported on a study  
published in 2008.  
[630] Each of Doran Ryan, Daniel Tomlak and Eliot Wayne Tunis implanted Proplast devices,  
generally in the period between 1983 and 1987, Doran Ryan in the United States, the other two  
in Canada. They all stopped, but not because of any general consensus or understanding. In his  
March 1989 letter to the editor of the Journal of Oral and Maxillofacial Surgery, Doran Ryan  
acknowledged the good faith of those involved in promoting the product and that there were  
others who saw these implants as having had “great success”. He referred to three papers (1987,  
1990 and 1992) which were favourable in their views. He invited Charles Homsy to attend a  
conference to discuss problems with the product. Doran Ryan continued to investigate to come to  
a better understanding of the product. In the years leading to his arrival in Thunder Bay, Daniel  
Tomlak worked with top oral maxillofacial surgeons in the United States. They supported the use  
of Proplast devices. He introduced these devices to his colleagues in Thunder Bay. As a result of  
an informal discussion in Vancouver he stopped. This does not support the idea of a general  
consensus. Some people made favourable comments. There was no discussion of bone  
deterioration or fragmentation of the material. The substance of the expressed concern was that  
more of the Proplast devices than had been expected had been taken out (explanted). The study  
referred to by Elliot Wayne Tunis was limited and the conclusion mixed, some patients did well  
while others did not.  
[631] There was no certain understanding of Proplast that would have driven any reasonable  
person responsible for its regulation to conclude it was dangerous. Over the period of time  
referred to, the understanding of the impact of Proplast developed and evolved through its use,  
experience and analysis. As it is, the first evaluator, Nancy Shadeed, did not accept the  
submissions seeking Notices of Compliance as being complete. She rejected them. The second  
evaluator, Richard Lawuyi, rejected those that were specifically dedicated to use as  
temporomandibular implants but recommended those that were more general (but directed to  
non-orthopaedic uses) for the issuance of such notices. The actual use was left to the medical  
professionals to judge.  
[632] It is concerning that Richard Lawuyi said he did not read the product monograph. It is  
not, as he suggested, just promotional material. He should have read the one prepared in respect  
of “Block and Sheeting (the one dealing with the products that received Notices of Compliance).  
In the end there is no suggestion that his failure to do so had any practical impact. There is no  
demonstrated example of any individual who was implanted with Block and Sheeting in the time  
Page: 209  
period after the Notices of Compliance were issued. In any case “Indications” and  
“Contraindications” are nothing more than suggestions from a “positive” and “negative”  
perspective. On the one hand, the prospective use is advisable, on the other hand, it would be ill-  
advised. The ultimate decision is for the surgeon with the particular issue, confronted by the  
particular patient, in mind. The idea, raised in the Reply Submissions of the Plaintiff as to “the  
depth and degree of the review [conducted by Richard Lawuyi] of the 20 binders” that make up  
the 1988 submission, misses the point. For the most part, the applications for Notices of  
Compliance were refused. Where this is so, the Plaintiff can have no complaint. As to what form  
of product monograph that was actually sent out with any Block and Sheeting that was sold, I  
point out, again, there is no evidence that any doctor or surgeon read and was misled by the  
product monograph. Such a reading would not likely be credible given the import of  
“Indications” and “Contraindication” in these Monographs and the ultimate responsibility borne  
by the medical professionals to determine whether a particular use of these products would be or  
could be helpful to a patient. Even so, I repeat, there is no substantive evidence that any one was  
implanted with Block and Sheeting in the temporomandibular joint (or, for that matter, anywhere  
else). In these circumstances the proposition that Richard Lawuyi says now, 35 years after these  
implants were put in place, that the product monograph for Block and Sheeting should have been  
clarified does not change the overall impact of questions raised by this document.  
[633] I return to the question of whether Francine Jacques (Gaudette) was misled into negligent  
conduct by her mistaken belief that certain of the Vitek Proplast temporomandibular joints were  
subject to Notices of Compliance when they were not and her supposed subsequent failure to  
stop their importation. I note this is a hypothetical question because there is no evidence that any  
of these particular devices were on any import list produced and reviewed by Francine Jacques  
(Gaudette) or, for that matter, that anyone was implanted with them. I also point out that, as  
matters stand, following the completion and delivery of the Submissions of the Plaintiff, it is  
difficult for the Plaintiff to rely on this theoretical error because, as those submissions reveal, it is  
the Plaintiff’s position that these devices were in fact approved. This being so there would be no  
basis to stop them from being imported. I have made clear I do not accept this proposition. The  
fact remains that there is no obligation under the Medical Devices Regulation to stop all products  
without Notices of Compliance at the border. To say otherwise would suggest that any duty of  
care imposed on the Health Protection Branch would extend to what happens at the border or,  
conversely covers the border authorities such that they would be negligent for not stopping every  
device lacking a Notice of Compliance. A reading of the Customs Surveillance Program makes  
clear that the border review is not designed to be a wall that blocks importation. It is a tool to be  
used as part of a co-operative program to bring to market medical devices which had a prospect  
of assisting patients. Insofar as refusing entry is concerned the program was to improve the  
capability to stop product at the border, not to close off the importation of products. If I were  
required to do so I would not find that the actions of Francine Jacques (Gaudette) contribute to  
negligence by the Crown.  
[634] This leaves the question of whether, assuming a duty of care to be present, the Crown  
breached that duty in its handling of the recall. There is nothing in the actions of those acting in  
the name of the Crown that suggests a breach of any supposed duty of care. The inspections  
carried out before and after the recall were responsibly prepared for, undertaken, reviewed and  
followed up on. The published notices and warnings were considered and, in the circumstances,  
Page: 210  
comprehensive. The decision not to notify every doctor, surgeon and patient was considered and  
reasonable.  
[635] I answer the common issues, as follows:  
1. Canada did not owe a duty of care to class members.  
2. Assuming Canada did owe a duty of care to class members, the applicable standard of  
care was not breached.  
3. Through the evidence produced through doctors, patients, researchers and regulators it  
has been demonstrated that Vitek Proplast temporomandibular joint implants can cause  
injury to those receiving them. The actual injury caused, in any particular case, would  
require individual inquiry.  
[636] It follows that the action is dismissed.  
COSTS  
[637] Rule 12.05 (1) (c) of the Rules of Civil Procedure makes it a requirement that a judgment  
in a class proceeding account for the distribution of costs:  
A judgment in a class proceeding…shall contain directions with respect to,  
(c)  
the payment of costs of the proceeding.  
[638] No submissions have been made as to costs of the trial. If the parties are unable to agree,  
as to costs, I may be spoken to.  
[639] In the absence of submissions, it is not possible for the Court to understand the position  
of the parties as to costs or to make any determination as to what, if any, award should be made.  
Nonetheless, it would be unusual not to have some introductory perspective. I think it fair to  
make these known to the parties, in the hope they may be helpful. This proceeding has taken  
much too long. As Master McGraw noted, and I have repeated, there is little, to my mind no  
purpose, in undertaking a review and assessment of responsibility for this. The record suggests  
such an examination would point amply in both directions.  
[640] There are wider implications to this delay than just the cost. There are people who have  
been waiting out the results of this proceeding for in excess of 20 years (for each of them the  
implants have been in place for a span of about 35 years). On a psychological level I expect, for  
them, this decision will be, at least, disappointing; on a practical level it is impossible to know  
the effect. There is a broad public interest in how the administration of justice is perceived and  
how it, in fact, impacts on those who are touched by it. I say this cognizant of section 31(1) of  
the Class Proceedings Act:  
Page: 211  
In exercising its discretion with respect to costs under subsection 131 (1) of  
the Courts of Justice Act, the court may consider whether the class proceeding  
was a test case, raised a novel point of law or involved a matter of public interest;  
but also, the comments of the judge who dealt with the original certification motion, heard in  
2007. He found the considerations raised by section 31(1) not to be pertinent to this case:  
Counsel for the plaintiff submitted – and defendant’s counsel disputed – that, in  
the circumstances of this case, the court’s discretion with respect to cost should be  
influenced by the provisions of section 31 of the CPA. The section authorises the  
court, in the exercise of its discretion, to consider whether the proceeding “was a  
test case, raised a novel point of law or involved a matter of public interest”. In  
my judgement, none of these considerations is relevant in this case. Class actions  
with respect to medical implants have been relatively numerous in Canada. Some  
have involved specifically-identified TMJ implants for which substantially similar  
claims to those in this action have been made. The possibility that the ultimate  
decision in this case like that in any class proceeding may be influential in the  
final disposition, or a settlement, of the other cases is not, in my opinion,  
sufficient to make a “test case”. Although all the cases turn on their own facts, the  
points of law in the specific implant cases as distinct from a case like Drady v.  
The Attorney General of Canada [2007] O.J. No. 2812 in which generic industry-  
wide claims were made are sufficiently similar to foreclose a finding of novelty  
for the purposes of section 31. Nor do I believe this case falls within the range of  
those that are to be considered to have public interest because they have “some  
specific special significance for, or interest to, the community at large is on the  
members of the proposed class”: Pearson v. Inco Ltd. (2006), 267 D.L.R. (4th)  
111, at para. 9.695  
[641] For the purpose of these observations, I say only that the judge cannot have foreseen that  
it would take a further 12 years to resolve these issues. There was a time when the Crown was  
not permitted to seek costs. To the extent that in-house counsel were relied on, they were paid  
anyway. There was no additional cost to the Crown in carrying out the proceeding. There was  
also a general recognition that the Crown represents us all. In the normal course costs would  
follow the event. However, in all the circumstances of this case, and in recognition of the values  
considered at that earlier time, I wonder whether this is a case where no costs should be awarded;  
each party would bear its own.  
Lederer J.  
695 Taylor v. Canada (Endorsement as to Costs, January 15, 2008) (Trial Record at T. 31, para. 10)  
Page: 212  
Released: February 27, 2020  
CITATION: Taylor v. Canada (Attorney General), 2020 ONSC 1192  
COURT FILE NO.: CV-181819  
DATE: 20200227  
ONTARIO  
SUPERIOR COURT OF JUSTICE  
BETWEEN:  
KATHRYN ANNE TAYLOR  
Plaintiff  
and –  
THE ATTORNEY GENERAL OF CANADA  
Defendant  
DEFENDANT REASONS FOR JUDGMENT  
Lederer, J.  
Released: February 27, 2020  


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